The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.

Device Description

The AmnioStat-FLM-PG Kit is an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity. The AmnioStat-FLM-PG Kit is comprised of five (5) components and a disposable agglutination cards (cardboard with laminate). The five (5) components that comprise the kit include three (3) kit controls, Negative Control, Catalog #91013, Low Positive Control, Catalog #91027, High Positive Control, Catalog #91028, two (2) reagents, Reagent A, Catalog #91012 and Reagent B, Catalog #91029, and one (1) Buffer, Catalog #91011. The three (2) controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit are run with each test. The AmnioStat-FLM-PG Kit can be used to run six (6) patient test samples. Each patient sample is run on an individual agglutination card with a set of controls. The AmnioStat-FLM-PG Kit is a next generation kit based upon the same immunological agglutination test as AmnioStat-FLM (K822150) previously cleared for marketing. The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit. The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable. The AmnioStat-FLM (K822150) is performed on a glass slide that requires the use of a mirror to distinguish and differentiate the kit controls based upon clarity of the background and the size of the agglutinated particles. The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls.

AI/ML Overview

The provided text describes a 510(k) submission for the AmnioStat-FLM-PG Kit, an immunological semi-quantitative agglutination test for determining the presence of phosphatidylglycerol (PG) in human amniotic fluid to assess fetal lung maturity.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the AmnioStat-FLM-PG Kit. Instead, the performance is described qualitatively and through a comparative study.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence to Predicate Device (AmnioStat-FLM K822150)	- "The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit."- Clinical comparison data for 73 patient samples yielded "no false positive test results" and "demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product." This implies comparable accuracy to the predicate for determining the presence of PG.
Ease of Use / User-Friendliness (Improvement over predicate)	- "The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable."- "The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls."- "The response and feedback from the laboratories that evaluated the kit indicates it was well received in terms of its application, ease of use..."
Effectiveness in Determining Fetal Lung Maturity (as indicated by PG presence in amniotic fluid)	- "...effectiveness in the determining fetal lung maturity in human amniotic fluid."- The comparative study with 73 patient samples reported "no false positive test results" and confirmed performance "in accordance with the intended use," which is to identify PG for fetal lung maturity assessment.
Reliable Control Functionality	- "Functionality of the three (3) kit controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit with regards to differentiation in appearance is performed as a condition of release." (This is a manufacturing quality control, not a study outcome).
Compliance with Regulation (21 CFR Section 862.1455)	- "meets the criteria as outlined in 21 CFR Section 862.1455, Lecithin/Sphingomyelin ratio in amniotic fluid test system." (This is a self-assessment statement).

Summary of Acceptance: The acceptance is primarily based on demonstrating a substantially equivalent performance to the predicate device, with an improvement in ease of use and clarity of results. Specific quantitative performance metrics like sensitivity, specificity, or PPV/NPV are not provided in the summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 73 patient samples during the clinical comparison study.
Data Provenance: The study involved two (2) clinical laboratories. The country of origin is not specified but implied to be the US given the submission to the FDA. The data is retrospective in nature, as indicated by "clinical comparison data was also generated for seventy-three (73) patient samples that were tested between the two (2) clinical laboratories." This suggests pre-existing samples or samples collected and analyzed for comparison, rather than a prospective study designed to evaluate the new device exclusively from scratch.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications. The "clinical comparison data" likely refers to results from the predicate device, AmnioStat-FLM (K822150), being used as the comparative "truth" or gold standard.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. It describes a comparison between the new device and the predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly performed or described. The study was a comparison of results between two devices on patient samples, not an evaluation of human readers' performance with and without AI assistance (as this is a diagnostic test kit, not an AI-based imaging interpretation tool). Therefore, no effect size for human reader improvement with AI assistance is applicable or reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this was a standalone performance evaluation of the diagnostic test kit itself. The AmnioStat-FLM-PG Kit is an in-vitro diagnostic device designed to provide a result directly, not an algorithm that assists a human in interpretation. The "performance data" section describes the kit's performance rather than human performance with the kit.

7. The Type of Ground Truth Used

The ground truth used was implied to be the results obtained from the predicate device, AmnioStat-FLM (K822150). The document states, "The results of the comparison study yielded no false positive test results and demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product." This indicates the predicate device's findings were used as the reference to assess the new device's accuracy (specifically, in terms of false positives). The ultimate ground truth relates to the presence of phosphatidylglycerol, which the predicate device is also designed to detect.

8. The Sample Size for the Training Set

The document does not mention a separate training set. This is not an AI/machine learning device that typically requires distinct training, validation, and test sets. It's a chemical/immunological diagnostic assay. The samples mentioned (73 patient samples) are for the clinical comparison study, analogous to a test or validation set.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described for this type of device, this question is not applicable.

Summary

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OC1 1 8 2006

Kcx61549

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)

Submitted by:	Irvine Scientific Sales Co., Inc.2511 Daimler StreetSanta Ana, CA 92705-5588
	Telephone: (800) 437-5706Facsimile: (949) 261-6522
	Contact: Wendell Lee, Pharm. D.
	Date Submitted: June 2, 2006

Device Identification:

Trade Name:	AmnioStat-FLM-PG
Common Name:	AmnioStat
Classification Name:	Lecithin/Sphingomyelin Ratio in Amniotic Fluid(21 CFR, 862.1455)

Predicate Device:

AmnioStat-FLM (K822150), Lecithin/Sphingomyelin ratio in amniotic fluid test system (21 CFR 862.1455)

Description:

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The three (2) controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit are run with each test. The AmnioStat-FLM-PG Kit can be used to run six (6) patient test samples. Each patient sample is run on an individual agglutination card with a set of controls. Please refer to the photographs of the AmnioStat-LM-PG Kit presented in Appendix D of the submission.

The AmnioStat-FLM-PG Kit is a next generation kit based upon the same immunological agglutination test as AmnioStat-FLM (K822150) previously cleared for marketing. The immunological agglutination reaction is the same between the AmnioStat-FLM (K822150) and the AmnioStat-FLM-PG kit. The AmnioStat-FLM-PG Kit incorporates the use of Sudan Black B into one of the kit reagents which makes the differentiation of the three (3) kit controls more distinguishable. The AmnioStat-FLM (K822150) is performed on a glass slide that requires the use of a mirror to distinguish and differentiate the kit controls based upon clarity of the background and the size of the agglutinated particles. The AmnioStat-FLM-PG is performed on a disposable agglutination card that is white and does not require the use of a mirror to distinguish and differentiate the kit controls.

Intended Use:

for use as an immunologic intended AmnioStat-FLM-PG is semiguantitative agglutination test for determining the presence of phosphatidylglycerol in human amniotic fluid at concentrations indicative of fetal lung maturity.

The AmnioStat-FLM-PG test kit is to be used by laboratory personnel in a hospital and/or clinical laboratory.

Performance Data:

The AmnioStat-FLM-PG Kit has been evaluated by five (5) independent field laboratories that currently use the AmnioStat-FLM test kit. The response

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and feedback from the laboratories that evaluated the kit indicates it was well received in terms of its application, ease of use, and effectiveness in the determining fetal lung maturity in human amniotic fluid.

In addition, clinical comparison data was also generated for seventy-three (73) patient samples that were tested between the two (2) clinical laboratories. The results of the comparison study yielded no false positive test results and demonstrated that the AmnioStat-FLM-PG kit performs in accordance with the intended use of the product.

Additional Information:

Functionality of the three (3) kit controls (negative, low positive, and high positive) in the AmnioStat-FLM-PG Kit with regards to differentiation in appearance is performed as a condition of release. Please refer to the proposed labeling presented in Section 14 of this submission.

Conclusion:

The results from the field testing of this product demonstrates that the AmnioStat-FLM-PG Kit is suitable for its intended use, meets the criteria as outlined in 21 CFR Section 862.1455, Lecithin/Sphingomyelin ratio in amniotic fluid test system.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Wendell Lee, Pharm.D. Vice President Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588

OCT 1 8 2006

Re: K061549

Trade/Device Name: AminoStat-FLM-PG Regulation Number: 21 CFR 862.1455 Regulation Name: Lecithin/sphingomyelin ratio in amniotic fluid test system Regulatory Class: Class II Product Code: JHG Dated: September 25, 2006 Received: September 26, 2006

Dear Mr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbaanding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins lotter will anow you w organ marketing of substantial equivalence of your device to a legally promation notineditor. "The PD's in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, rr you dost o specific instition and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may overn of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K061549

Device Name:

AmnioStat-FLM-PG

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

C.A.C.

Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061549

Regulation Number and Section

§ 862.1455 Lecithin/sphingomyelin ratio in amniotic fluid test system.

(a)
Identification. A lecithin/sphingomyelin ratio in amniotic fluid test system is a device intended to measure the lecithin/sphingomyelin ratio in amniotic fluid. Lecithin and sphingomyelin are phospholipids (fats or fat-like substances containing phosphorus). Measurements of the lecithin/sphingomyelin ratio in amniotic fluid are used in evaluating fetal maturity.(b)
Classification. Class II.