← Product Code [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI) · K965227

# OSOM CLASSIC HCG-URINE TEST (115) (K965227)

_Wyntek Diagnostics, Inc. · JHI · Feb 4, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K965227

## Device Facts

- **Applicant:** Wyntek Diagnostics, Inc.
- **Product Code:** [JHI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI.md)
- **Decision Date:** Feb 4, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

## Device Story

Lateral flow immunochromatographic assay; detects hCG in urine samples. Device utilizes membrane coated with anti-hCG antibodies; presence of hCG results in blue test line formation. Used in clinical or point-of-care settings; operated by healthcare professionals. Provides qualitative visual output; assists in pregnancy confirmation. Benefits patient through rapid, early detection.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Immunochromatographic assay; membrane-based; anti-hCG antibody coating; visual colorimetric readout (blue line).

## 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.

## Predicate Devices

- Quidel RapidVue hCG Test
- Abbott TestPack Plus hCG Urine Test

## Submission Summary (Full Text)

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>
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K965227

# 8. 510 (k) Summary FEB - 4 1997

Wyntek Diagnostics Inc.
ISO9001
EN46001
Certified
6146
Nancy Ridge Drive
Suite 101
San Diego, CA 92121
Tel: 619-452-3198
Fax: 619-452-3258

Submitter: Wyntek Diagnostics, Inc.
6146 Nancy Ridge Dr. Ste. 101
San Diego, CA 92121
Tel: 619-452-3198
Fax: 619-452-3258

Contact Person: Shu-Ching Cheng

Product Name:
Proprietary Name: OSOM™ Classic hCG-Urine Test
Common Name: hCG Urine Pregnancy Test Kit
Classification Name: Human chorionic gonadotropin (hCG) test
Classification Number: 75JHI

Intended Use: The OSOM™ Classic hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy.

Description: OSOM Classic hCG-Urine Test uses color immunochromatographic technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

Substantial Equivalence: OSOM Classic hCG-Urine Test is substantially equivalent to Quidel RapidVue hCG Test and Abbott TestPack Plus hCG Urine Test. All three tests utilize immunochromatographic technology and anti-hCG antibodies to detect hCG in urine. All three tests interpret the results through the development of the color lines.

Applicant Signed: Shu-Ching Cheng
Date: 1/14/97

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K965227](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JHI/K965227)

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