← Product Code [DHA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA) · K974425

# BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST (K974425)

_Princeton BioMeditech Corp. · DHA · Dec 24, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA/K974425

## Device Facts

- **Applicant:** Princeton BioMeditech Corp.
- **Product Code:** [DHA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/DHA.md)
- **Decision Date:** Dec 24, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

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

## Device Story

BioSign™ hCG-One Step Pregnancy Test is an in vitro diagnostic immunoassay. Device detects Human Chorionic Gonadotropin (hCG) in urine samples. Intended for professional use in hospitals, clinical laboratories, and physicians' offices. Provides qualitative results for early pregnancy confirmation. Operates via lateral flow immunoassay principle; visual interpretation of test line indicates presence of hCG. Assists clinicians in confirming pregnancy status.

## Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

## Technological Characteristics

In vitro diagnostic immunoassay; lateral flow format for qualitative urine analysis. Professional use device.

## Regulatory 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. 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.

## Submission Summary (Full Text)

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{0}

HUMAN SERVICES LLP
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

DEC 24 1997

Jemo Kang, Ph.D.
Director
Princeton BioMeditech Corporation
P.O. Box 7139
Princeton, New Jersey 08543-7139

Re: K974425
BioSign™ hCG-One Step Pregnancy Test
Regulatory Class: II
Product Code: DHA
Dated: November 20, 1997
Received: November 21, 1997

Dear Dr. Kang:

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 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.

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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/dsmamain.html".

Sincerely yours,

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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11/13/97 THU 11:55 FAX 301 5945940
FDA DCLD
002

Page 1 of 1

510(k) Number (if known): K974425

Device Name: BioSing hCG - One Step Pregnancy Test

Indications For Use:
Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physicians' offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in urine for the early confirmation of pregnancy.

[Signature]
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K974425

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional Use ☑
Prescription Use ☑
(Per 21 CFR 801.109)

OR

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

11/13/97 THU 12:48 [TX/RX NO 9315] 002

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