CLINITEK HCG TEST STRIPS

K971209 · Bayer Corp. · JHI · Apr 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971209
• Device Name: CLINITEK HCG TEST STRIPS
• Applicant: Bayer Corp.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Apr 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

CLINITEK® hCG Test Strips are for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.

Device Story

CLINITEK® hCG Test Strips are immunochromatographic reagent strips used with CLINITEK 50 and 100 Urine Chemistry Analyzers. Input: urine sample applied to strip. Principle: monoclonal anti-beta hCG antibody-dye conjugate binds hCG; complex migrates to zone of immobilized polyclonal anti-alpha hCG, forming red line (positive). Procedural control zone forms blue line indicating sufficient saturation. Analyzers function as reflectance photometers, measuring color/intensity of reflected light. Algorithm converts reflectance to qualitative 'positive' or 'negative' result on display. Used in clinical labs/point-of-care by professionals. Output: visual/digital qualitative pregnancy status. Benefit: rapid, automated pregnancy detection.

Clinical Evidence

Performance assessed per FDA Reviewer’s Guidance for hCG IVDs and NCCLS I/LA10-P guidelines. Internal and external field evaluations conducted using clinical urine specimens. Results demonstrate performance equivalence to predicate devices.

Technological Characteristics

Immunochromatographic assay; monoclonal anti-beta hCG antibody-dye conjugate; polyclonal anti-alpha hCG capture zone. Reflectance photometry sensing. Compatible with CLINITEK 50 and 100 analyzers. Qualitative output.

Indications for Use

Indicated for qualitative detection of hCG in urine for early pregnancy diagnosis in professional clinical, physician office, and point-of-care settings.

Regulatory Classification

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.

Predicate Devices

• QuickVue® One-Step HCG Combo (K971209)
• Test Pack +Plus hCG Combo (K971209)

Submission Summary (Full Text)

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K971209
APR - 4 1997
Bayer Corporation, Business Group Diagnostics
CLINITEK® hCG Test Strips
510(k) Safety and Effectiveness Summary
Page 1 of 2

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: March 12, 1997

Submitter: Bayer Corporation, Business Group Diagnostics

Address: 1884 Miles Avenue, P. O. Box 70
Elkhart, IN 46515
[phone]

Contact: Rosanne M. Savol, R.A.C.
Manager, Regulatory Affairs

Device: Trade/Proprietary Name: CLINITEK® hCG Test Strips for Detection of hCG in Urine
Common/Usual Name: Urine Pregnancy Test
Document Control Number: K97

Classification Name: Human Chorionic Gonadotropin (hCG) Test System

Predicate Devices: QuickVue® One-Step HCG Combo
Manufactured by QUIDEL Corporation
Test Pack +Plus hCG Combo
Manufactured by Abbott Laboratories

Device Description: CLINITEK® hCG Test Strips are unitized reagent strips used with the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers. Each bottle contains 25 test strips.

Intended Use: CLINITEK® hCG Test Strips are for the qualitative measurement of Human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. CLINITEK hCG Test Strips are for professional use in clinical laboratories, physician offices and other point-of-care healthcare locations.

{1}

Bayer Corporation, Business Group Diagnostics
CLINITEK® hCG Test Strips
510(k) Safety and Effectiveness Summary
Page 2 of 2

## Technological Characteristics:

The CLINITEK® hCG Test Strip uses immunochromatographic assay methods for detecting human chorionic gonadotropin (hCG) in urine. It is intended to be read instrumentally on the CLINITEK 50 and CLINITEK 100 Urine Chemistry Analyzers. The first zone of the test strip contains antibody to hCG (monoclonal anti-beta hCG) coupled with red dye. The urine rehydrates this zone and mobilizes the antibody-dye. Any hCG present will bind with the antibody-dye conjugate. Another zone of hCG specific antibodies (polyclonal anti-alpha hCG) is bound to the strip. As the hCG-antibody-dye moves along the strip it will bind to this zone producing a red line (positive result). A similar migration pattern occurs with the built-in procedural control feature. A blue line appears which indicates that a sufficient amount of urine has saturated the test strip. If there is no hCG present in the urine only the blue line will appear (negative result). The CLINITEK 50 and CLINITEK 100 Urine Chemistry Analyzers are relectance photometers that analyze the color and intensity of the light reflected from the test strip. The algorithm in the instruments converts the measured reflectance and displays the results as either “positive” or “negative” on the instrument display panel. No calculations are required by the user.

## Assessment of Performance:

The performance of CLINITEK® hCG Test Strips was assessed according to the FDA Reviewer’s Guidance Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD’s)¹ and the National Committee for Clinical Laboratory Standards (NCCLS) guideline Chorionadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application². Studies were performed in-house and in external field evaluations utilizing clinical urine specimens.

## Conclusion:

The results of the internal and external studies demonstrate that CLINITEK® hCG Test Strips are equivalent in performance to predicate devices currently in interstate commerce and suitable for use in point-of-care locations.

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¹ Review Criteria for Assessment of Human Chorionic Gonadotropin (hCG) In Vitro Diagnostic Devices (IVD’s). Department of Health and Human Services, Food and Drug Administration. CDRH, 2098 Gaither Road, Rockville, MD 20850, 1995.
² Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Proposed Guideline. National Committee for Clinical Laboratory Standards (NCCLS) Document I/LA10-P (ISBN 1-56238-275-6). NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA 19087, 1995.