The One-Step Double-Chek™ Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine and serum, for the early detection of pregnancy. For Laboratory Professional Use Only.

Device Description

The One-Step Double-Chek™ Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine and serum. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Double-Chek™ Pregnancy Test will detect hCG in urine and serum at a concentration level of 25 mIU/ml. The One-Step Double-Chek™ Pregnancy Test will be sold for professional use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the One-Step Double-Chek™ Pregnancy Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	100%	100%
Specificity	100%	100%
Agreement	100%	100%

Note: The document states, "The One-Step Double-Chek™ Pregnancy Test when compared with another commonly used pregnancy test (Abbott TestPack Plus) demonstrated 100% performance." This implies that the acceptance criteria for sensitivity, specificity, and agreement were 100% when compared to the predicate device.

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

Sample Size: The document does not explicitly state the total number of samples used in the clinical trial. It only states that a "clinical trial was done."
Data Provenance: The document does not specify the country of origin. It does state that "A trained Laboratory Technician performed testing in a CLIA registered laboratory," which suggests a professional laboratory setting. The study appears to be prospective as it's a clinical trial comparing the new device to an existing one.

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

The document implies that the ground truth was established by medical professionals as it states: "All pregnancy results were confirmed by physical examination and/or ultrasound."
It does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience"). It only identifies them broadly as professionals capable of performing physical examinations and ultrasounds.

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method like 2+1 or 3+1. The ground truth was established by "physical examination and/or ultrasound," which implies a direct medical assessment rather than a consensus among multiple reviewers of the test results themselves.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or conducted in the context of human readers improving with AI vs. without AI assistance. The comparison was between the One-Step Double-Chek™ Pregnancy Test and the Abbott TestPack Plus, both used by a laboratory technician. The study does not involve AI or human reader assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "Performance Data" section directly reports the device's performance (sensitivity, specificity, agreement) when compared to a predicate device. This is a standalone assessment of the device's accuracy in detecting hCG. There is no human-in-the-loop component mentioned for the reported performance metrics.

7. Type of Ground Truth Used

The type of ground truth used was outcomes data and expert assessment. Specifically, "All pregnancy results were confirmed by physical examination and/or ultrasound." This indicates that actual clinical outcomes (pregnancy status) confirmed by medical examination were used as the gold standard.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is a diagnostic test where performance is typically evaluated on a test set against a known ground truth, rather than having a distinct training and test set in the machine learning sense. The device's performance is demonstrated through its clinical trial on a single set of samples.

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

As no training set is mentioned, this information is not applicable or provided.

Summary

{0}------------------------------------------------

510 (K) SUMMARY

Date of Summary: October 7, 1999

Product Name:

One-Step Double-Chek™ Pregnancy Test

Sponsor:

Bio-Medical Products Corp. 10 Halstead Road Mendham, NJ 07945

Correspondent:

MDC Associates Fran White Regulatory Consultant 15 Oak Street Beverly Farms, MA 01915

Substantially Equivalent Devices:

Product: Abbott TestPack Plus Manufactured by: Abbott Diagnostics

PRODUCT DESCRIPTION:

{1}------------------------------------------------

INTENDED USE:

SUMMARY OF TECHNOLOGY:

The One-Step Double-Chek™ Pregnancy Test employs a unique combination of monoclonaldye conjugate and polyclonal-solid phase antibodies to selectively identify human Chorionic Gonadotropin (hCG) in urine and serum. As the urine or serum sample flows through the absorbent portion of the device, the antibody-dye conjugate binds to the hCG forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band if hCG concentration is equal to or greater than 25 mIU/ml. In the absence of hCG, there is no line in the reaction zone. Unbound conjugate binds to the reagents in the control zone, producing a pink-rose color band. demonstrating that the reagents are functioning correctly.

PERFORMANCE DATA:

A clinical trial was done to compare the performance of the One-Step Double-Chek™ Pregnancy Test. These data clearly demonstrates the performance of the One-Step Double-Chek ™ Pregnancy Test by Bio-Medical is substantially equivalent to the Abbott TestPack Plus TM.

Sensitivity =	100%
Specificity =	100%
Agreement =	100%

STATEMENT OF SAFETY AND EFFICACY:

The One-Step Double-Chek™ Pregnancy Test when compared with another commonly used pregnancy test (Abbott TestPack Plus) demonstrated 100% performance.

All pregnancy results were confirmed by physical examination and/or ultrasound.

{2}------------------------------------------------

These data clearly demonstrate the safety and efficacy of the One-Step Double-Chek Pregnancy Test and further confirm that the accuracy, sensitivity and specificity of this product when compared to a substantially equivalent device currently being sold for professional use. A trained Laboratory Technician performed testing in a CLIA registered laboratory.

Bio-Medical Products Corporation confirms that any/all data provided in this submission may be released upon request.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 8 1999

Biomedical Products Corporation c/o Ms. Fran White MDC Associates 15 Oak Street Beverly Farms, Massachusetts 01915

K992915 Re:

Trade Name: One-Step Double-ChekTM Pregnancy Test Regulatory Class: II Product Code: JHI Dated: October 7, 1999 Received: October 21, 1999

Dear Ms. White:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Page 18 of 29

510(k) Number: (if known) K992915
Device Name: One-Step Double-Chek™ Pregnancy Test

Indication for Use:

Stan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 16992915

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over The Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.