PERFECTA PREGNANCY TEST

K965184 · Wyntek Diagnostics, Inc. · LCX · Feb 4, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965184
• Device Name: PERFECTA PREGNANCY TEST
• Applicant: Wyntek Diagnostics, Inc.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Feb 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

Perfecta Pregnancy Test is a pregnancy test intended for home use.

Device Story

Perfecta Pregnancy Test; lateral flow immunochromatographic assay; detects human chorionic gonadotropin (hCG) in urine samples. Device utilizes membrane coated with anti-hCG antibodies; presence of hCG results in blue test line formation. Intended for home use by lay users. Provides qualitative visual readout for pregnancy detection; assists in early pregnancy identification. No complex instrumentation or remote processing required.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunochromatographic assay; membrane-based antibody coating; visual colorimetric readout; standalone test kit.

Indications for Use

Indicated for home use by individuals to detect the presence of hCG in urine for the purpose of pregnancy testing.

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

• Abbott TestPack Plus hCG Urine Test
• Warner-Lambert e.p.t Pregnancy Test
• Carter Wallace FIRST RESPONSE Pregnancy Test

Submission Summary (Full Text)

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K965184

Wyntek diagnostics
FEB - 4 1997

# 8. 510 (k) Summary

Wyntek Diagnostics Inc.
ISO9001
EN46001
Certified
6146
Nancy Ridge Drive
Suite 101
San Diego California 92121
USA

Submitter: Wyntek Diagnostics, Inc.
6146 Nancy Ridge Dr. Ste. 101
San Diego, CA 92121
Tel: [phone]
Fax: [phone]

Contact Person: Shu-Ching Cheng

Product Name:
Proprietary Name: Perfecta™ Pregnancy Test
Common Name: OTC Pregnancy Test Kit
Classification Name: Kit, Test, Pregnancy, HCG, OTC
Classification Number: 75LCX

Intended Use: Perfecta Pregnancy Test is a pregnancy test intended for home use.

Description: Perfecta Pregnancy 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: Perfecta Pregnancy Test is substantially equivalent to Abbott TestPack Plus hCG Urine Test, Warner-Lambert e.p.t Pregnancy Test and Carter Wallace FIRST RESPONSE Pregnancy Test. All these 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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