STATUS HCG SERUM/URINE

• K Number: K020439
• Device Name: STATUS HCG SERUM/URINE
• Manufacturer: PRINCETON BIOMEDITECH CORP.
• Date Cleared: 2002-05-23 ( 101 days)
• Product Code: JHI
• Regulation Number: 862.1155
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physician’ offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy.

Device Description

Status hCG™ Serum/Urine is simple one step immunochromatographic test for the rapid, qualitative detection of hCG in serum or urine.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
100% correlation with predicate device for urine samples.	100% correlation with QuickVue® hCG Combo Test
100% correlation with predicate device for serum samples.	100% correlation with QuickVue® hCG Combo Test

Note: The 510(k) summary directly states the outcome of the study as the acceptance criteria. For devices showing substantial equivalence, the primary "acceptance criterion" is often demonstrating performance that is equivalent to or better than a legally marketed predicate device. In this case, "100% correlation" to the predicate device is presented as the meeting of this implicit criterion.

Study Details

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

• Sample Size: 100 specimens (50 negative, 50 positive) for urine tests AND 100 specimens (50 negative, 50 positive) for serum tests.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• This information is not provided in the 510(k) summary. The ground truth seems to be established by the results of the predicate device, QuickVue® hCG Combo Test.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified as the comparison is against a single predicate device's results, not an independent ground truth established by multiple experts.

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

• No, a multi-reader multi-case comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device, not human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, this study represents a standalone performance evaluation of the Status hCG™ Serum/Urine device. It functions as an IVD (in vitro diagnostic) test, and its results are read directly, not through an algorithm requiring human-in-the-loop interaction in the context of this 510(k).

7. Type of Ground Truth Used:

• The ground truth for this study was established using the results from a legally marketed predicate device, the QuickVue® hCG Combo Test. The language "100% correlation when 100 specimens were compared" indicates the predicate device's results were used as the reference standard.

8. Sample Size for the Training Set:

• Not applicable/Not specified. This device is an immunochromatographic test, not an AI/machine learning algorithm that requires a training set in the conventional sense.

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

• Not applicable, as there is no training set for this type of diagnostic device.

Summary

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MAY 2 3 2002

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is: KO20439

1. Date of Summary: Feb.05, 2002

Princeton BioMeditech Corperation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE [phone] FAX [phone] Contact Person: Jemo Kang, Ph.D.

• 3. Device Name: Trade Names: Status hCG™ Serum/Urine BioSign™ hCG Serum/Urine
     Common or Usual Name: Immunoassay for detection of Human Gonadotropin in urine -

Classification Name: Immunosassay, human Chorionic Gonadotropin (hCG) (Clinical Chemistry Classification Device List)

• 4. Identification of legally marketed device to which claims equivalence: QuickVue hCG Combo Test by Quidel in Sandiego, CA
• 5. Device Description: Status hCG™ Serum/Urine is simple one step immunochromatographic test for the rapid, qualitative detection of hCG in serum or urine.
• 6. Intended Use: Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physician' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy.
• Equivalence: Status hCG™ is substantially equivalent to 7. Substantial premarketed device QuickVue® hCG Combo Test. Both products use the same immunochromatographic assay to detect hCG in serum or urine qualitatively. The tests demonstrated 100 % correlation when 100 specimens (50 negative and 50 positive) were compared for urine test or for serum test.
• Conclusion: The device is as safe, as effective, and performs as well as the legally marketed device OuickVue® hCG-Combo Test by Quidel Corp.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a symbol that resembles a stylized caduceus, with three lines representing the snake and a wavy line representing the staff.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 23. 2002

Kyung-ah Kim, Ph.D. Principal Scientist Princeton BioMeditech Corporation 4242 U.S. Route 1 Monmouth Junction, NJ 08852 1905

Re: K020439

Trade/Device Name: Status hCG™ Serum/Urine, BioSign™ hCG Serum/Urine Regulation Number: 21 CFR 862.1155 Regulation Name: Human chorionic gonadotropin (HCG) test system Regulatory Class: Class II Product Code: JHI Dated: April 22, 2002 Received: April 23, 2002

Dear Dr. Kim:

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 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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

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Page

120436 510(k) Number (if known):

. Device Name: Status hCG™ Serum/Urine, BioSign™ hCG Serum/Urine,

Indications For Use:

Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physician' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy.

Coops
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020439

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Professional Use: X Prescription Use: X (Per 21 CFR 801.109)

OR

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.