FERTILMARQ TEST KIT by EMBRYOTECH LABORATORIES, INC.

The FertilMARQ™ Test Kit is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples in duplicate. The kit contains components intended to hold, treat, and test collected semen (pre-coated collection cups, disposable pipettes, test cassettes), reagents intended to stain and wash semen samples collected on the test cassette. Positive and negative control wells are incorporated into the cassette design. In addition, the package insert and a Test Results form are included in the Kit. The Kit and all components are stored at room temperature. - The test operates by physical separation of sperm from seminal plasma and other semen components after a sample is dropped onto the filter incorporated into the test cassette. The staining reagent (Thiazine Blue) reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured and vield a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm, as compared to the negative control result, an intrinsic part of the assay.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for FertilMARQ™ Test Kit

This report details the performance of the FertilMARQ™ Test Kit, a semi-quantitative test for rapid sperm concentration analysis, and how it meets its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Test Set)
High Sensitivity	98% (identifying sperm concentration ≥ 20 million/mL)
High Specificity	98% (identifying sperm concentration < 20 million/mL)
High Accuracy	98%
High Positive Predictive Value	99%
High Negative Predictive Value	96%
Concordance with manual light microscopic method for ≥ 20M/mL samples	116 out of 117 samples correctly identified
Concordance with manual light microscopic method for < 20M/mL samples	43 out of 45 samples correctly identified
High Reproducibility across sites/time	48 out of 50 samples had corresponding results (2 sites, 24 hours apart)
High Reproducibility (Intra-laboratory, operators)	101 out of 102 samples had concordant results (same lab, 2 operators)
Low rate of inconclusive results (dilution study)	2 samples deemed borderline/inconclusive out of 32 total samples

Note: The document does not explicitly state acceptance criteria in a quantitative format (e.g., "Sensitivity must be >= 95%"). The reported performance metrics are presented as evidence of equivalence to the predicate device and the standard microscopic method, implying these are the benchmarks for acceptance.

2. Sample Size and Data Provenance for the Test Set

Sample Size:
- Clinical Evaluation: 162 semen samples
- Dilution Study: 32 semen samples (19 samples with sperm concentration ≥ 20 million/mL, 13 samples with sperm concentration < 20 million/mL)
- Reproducibility Studies (Site-to-site): 50 semen samples
- Reproducibility Studies (Intra-laboratory): 102 samples
Data Provenance: The studies were conducted at multiple sites: "a three site clinical evaluation" and "two sites" for reproducibility. The specific country of origin is not mentioned, and it is a retrospective study since the samples are being "evaluated."

3. Number and Qualifications of Experts for Ground Truth

The document does not specify the number of experts used to establish the ground truth or their qualifications.
The ground truth reference method is "standard manual microscopic analysis method" or "manual light microscopic method."

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The consensus appears to be based on the "standard manual microscopic analysis method" as the gold standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A formal MRMC comparative effectiveness study, comparing human readers with and without AI assistance, was not conducted.
This device is an in vitro diagnostic kit, not an AI-assisted diagnostic tool designed to augment human reader performance. The comparison is between the device's output and a standard manual laboratory method, not human interpretation.

6. Standalone Performance

Yes, a standalone performance study was done. The reported performance metrics (Sensitivity, Specificity, Accuracy, etc.) are for the FertilMARQ™ Test Kit functioning independently (algorithm only, without human-in-the-loop performance influencing the primary determination of concentration). The kit yields a "colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm."

7. Type of Ground Truth Used

The ground truth used was established by the standard manual microscopic analysis method for sperm concentration. This is a well-established laboratory method for semen analysis.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. This is likely because the device is a chemical-based in vitro diagnostic kit, not a machine learning model that would typically require a distinct training set. The development of such a kit typically involves biochemical optimization and validation rather than statistical model training.

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

Since a training set (in the context of machine learning) is not explicitly mentioned or implied for this type of device, the method for establishing its ground truth is not applicable or described in the provided text. The "training" for such a device would involve the iterative development and optimization of its chemical reactions and filter design to accurately reflect sperm concentration as determined by manual microscopy.

Summary

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K983473

080 17 1998

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

(1)	Submitter's name:	Embryotech Laboratories, Inc.
	Submitter's address:	323 Andover Street, Wilmington, MA 01887
	Submitter's telephone number:	(978) 658-4600
	Contact Person:	Ann D. McGonigle, Regulatory Affairs (508) 358-9114
	Date Summary Prepared:	September 30, 1998
(2)	Trade or proprietary device name:	FertilMARQ™ Test Kit
	Common or usual name:	Semen analysis test kit
	Classification name:	Obstetrics/gynecology
(3)	Legally marketed predicate device:	Semen Analysis Kit [Humagen Fertility Diagnostics] (K915229, 08/30/94)

(4) Subject device description:

The test operates by physical separation of sperm from seminal plasma and other semen components after a sample is dropped onto the filter incorporated into the test cassette. The staining reagent (Thiazine Blue) reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured and vield a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm, as compared to the negative control result, an intrinsic part of the assay.

(5) Subject device intended use:

The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination of male infertility.

(6) Performance data:

Equivalent results are obtained on semen samples analyzed by both the FerrilMAROTM Test Kit and the standard manual microscopic analysis method.

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510(k) Summary for FertilMARQTM Test Kit page 2

Of the 162 semen samples evaluated in a three site clinical evaluation, 117 had sperm concentrations equal to or above 20 million/mL and 45 had sperm concentrations below 20 million/mL. 116 out of 117 samples above 20 million/mL were correctly identified as positive and 43 out of 45 samples below 20 million/mL were correctly identified as negative by the FertilMARQ™ Test Kit, based on comparison to light microscopic method result. These data demonstrated the FertilMARO™ Test Kit Sensitivity = 98%; Specificity = 98%; Accuracy = 98%; Positive predictive Value = 99%; and Negative predictive value = 96%.

In a dilution study at the critical cutoff range, 18 of 19 semen samples with sperm concentrations above 20 million/mL were correctly identified, and 12 of 13 semen samples with sperm concentrations below 20 million/mL were correctly identified, based on comparison to result obtained by the manual light microscopic method. The two other samples were found to be borderline or inconclusive by the FertilMARQ Test Kit.

Reproducibility studies also demonstrated that corresponding results were obtained at two sites on the same sample in 48 out of 50 samples, even when semen samples were analyzed 24 hours apart. Each site had one discrepant negative finding where microscopic analysis found concentrations over 20 million/mL. Each laboratory testing the 50 samples had an overall accuracy of 97.5%.

Intra-laboratory testing at one of the clinical evaluation sites resulted in 101 of 102 samples tested having concordant results when the same semen sample was tested by two separate operators.

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10903 New Hampshire Avenue Silver Spring, MD 20993

Embryotech Laboratories, Inc. c/o Ms. Ann D. McGonigle Regulatory Consultant 323 Andover Street Wilmington, MA 01887

JUN 1 5 2012

Re: K983473

Trade/Device Name: FertilMARQTM Test Kit Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: September 30, 1998 Received: October 2, 1998

Dear Ms. McGonigle:

This letter corrects our substantially equivalent letter of December 17, 1998.

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of

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Page 2 - Ms. Ann D. McGonigle

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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C. Indications for use of the Device

Page 1 of 1

510(k) Number): Not known K983473

FertilMARQ™ Test Kit Device Name:

Indications for Use:

(

The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm I he Fermination to aid in the determination of male infertility.

(Please do not write below this line-continue on another page if needed)

ギ *

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Makeri

(D'Vision Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983473

Over-the-Counter Use Prescription Use_X Or (Per 21 CFR 801.109) (Optional Format 1-2-96)

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”