I need help with interpreting the GLP requirements:

The following was copied from a previous post, not mine:

"For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:

1. the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
2. the purpose of the studies is to characterize the safety of the product;
3. the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.

If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations."

My question is:
I am preparing a 510(k) for an IVD that detects "microorganisms" in human blood.  The performance studies for this submission include testing the IVD using human blood samples spiked with microorganisms as well as whole blood specimens from infected patients.  Do we therefore meet the requirement listed above specifically #1, i.e., "... studies performed on ...microorganisms..."?  Do we need to meet GLP?

I need help with interpreting the GLP requirements:

The following was copied from a previous post, not mine:

"For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:

1. the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
2. the purpose of the studies is to characterize the safety of the product;
3. the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.

If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations."

My question is:
I am preparing a 510(k) for an IVD that detects "microorganisms" in human blood.  The performance studies for this submission include testing the IVD using human blood samples spiked with microorganisms as well as whole blood specimens from infected patients.  Do we therefore meet the requirement listed above specifically #1, i.e., "... studies performed on ...microorganisms..."?  Do we need to meet GLP?

I need help with interpreting the GLP requirements:

The following was copied from a previous post, not mine:

"For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:

1. the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
2. the purpose of the studies is to characterize the safety of the product;
3. the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.

If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations."

My question is:
I am preparing a 510(k) for an IVD that detects "microorganisms" in human blood.  The performance studies for this submission include testing the IVD using human blood samples spiked with microorganisms as well as whole blood specimens from infected patients.  Do we therefore meet the requirement listed above specifically #1, i.e., "... studies performed on ...microorganisms..."?  Do we need to meet GLP?

GCLP regulation and accreditation standards define laboratory practices, which support human sample analysis and result reporting to medical professionals (e.g., physicians) for the purpose of diagnosis and/or treatment of patients or clinical research subjects. Typically, testing methods employed in support of GCLP activity represent government approved in-vitro diagnostic devices (e.g., US FDA approved and/or CE marked medical devices).

GLP regulations and guidance define laboratory requirements, which support non-human laboratory analysis for samples that are derived, primarily, from animal host systems (i.e., analysis of animal samples, which support non-clinical research studies).

I need help with interpreting the GLP requirements:

The following was copied from a previous post, not mine:

"For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:

1. the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
2. the purpose of the studies is to characterize the safety of the product;
3. the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.

If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations."

My question is:
I am preparing a 510(k) for an IVD that detects "microorganisms" in human blood.  The performance studies for this submission include testing the IVD using human blood samples spiked with microorganisms as well as whole blood specimens from infected patients.  Do we therefore meet the requirement listed above specifically #1, i.e., "... studies performed on ...microorganisms..."?  Do we need to meet GLP?

I need help with interpreting the GLP requirements:

The following was copied from a previous post, not mine:

"For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:

1. the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
2. the purpose of the studies is to characterize the safety of the product;
3. the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.

If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations."

My question is:
I am preparing a 510(k) for an IVD that detects "microorganisms" in human blood.  The performance studies for this submission include testing the IVD using human blood samples spiked with microorganisms as well as whole blood specimens from infected patients.  Do we therefore meet the requirement listed above specifically #1, i.e., "... studies performed on ...microorganisms..."?  Do we need to meet GLP?

I need help with interpreting the GLP requirements:

The following was copied from a previous post, not mine:

"For practical intents and purposes, remember that 21 CFR part 58 and the GLP requirements therein become mandatory only when three criteria are met:

1. the studies are non-clinical laboratory studies performed on animals, plants, microorganisms or subparts thereof;
2. the purpose of the studies is to characterize the safety of the product;
3. the studies are submitted, or are conducted for submission to, the FDA in support of an investigational or marketing approval/clearance.

If the studies do not meet these three criteria, then they are outside the intended scope of the GLP regulations."

My question is:
I am preparing a 510(k) for an IVD that detects "microorganisms" in human blood.  The performance studies for this submission include testing the IVD using human blood samples spiked with microorganisms as well as whole blood specimens from infected patients.  Do we therefore meet the requirement listed above specifically #1, i.e., "... studies performed on ...microorganisms..."?  Do we need to meet GLP?

"Q12: Do the GLP regulations (21 CFR Part 58) apply to in vitro diagnostic (IVD) devices?

A12: The GLP regulations only apply to nonclinical laboratory studies, which are defined as: "in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety." (21 CFR 58.3(d)) Studies intended to evaluate the performance of IVD devices to determine their safety typically utilize human subjects or specimens derived from human subjects and are therefore not subject to the GLP regulation.)"