QUICKSTICK ONE STEP PREGNANCY TEST(9010)

K962219 · Phamatech · LCX · Jul 23, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962219
• Device Name: QUICKSTICK ONE STEP PREGNANCY TEST(9010)
• Applicant: Phamatech
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Quickstick™ One Step HCG Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.

Device Story

Lateral flow immunoassay for qualitative hCG detection in urine; utilizes visual color sandwich immunoassay technology; antibody-hCG-antibody complex formation indicates presence of analyte. Used by lay users for home pregnancy testing. Provides visual qualitative result; assists in early pregnancy confirmation. Benefits patient through rapid, accessible pregnancy status determination.

Clinical Evidence

Clinical sample correlation study and blind labeled spiked HCG study performed. Correlation study (>99% agreement) compared against Quidel Rapidvue and Syntron Bioresearch Be Sure. Blind consumer study (n=158) demonstrated 100% sensitivity (79/79), 100% specificity (79/79), and 100% accuracy (158/158).

Technological Characteristics

Visual color sandwich immunoassay; lateral flow technology; antibody-based detection of hCG; qualitative output.

Indications for Use

Indicated for women suspecting pregnancy to qualitatively detect human chorionic gonadotropin (hCG) in urine.

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

• Unipath Clearview HCG
• Abbott Laboratories’ Fact Plus
• Syntron Bioresearch Be Sure Pregnancy Test

Reference Devices

• Quidel Rapidvue
• Syntron Bioresearch Be Sure Pregnancy Test

Submission Summary (Full Text)

{0}

K962219

Pt PHAMATECH

JUL 23 1996

9265 Activity Road, # 112/113

San Diego, California 92126 USA

Tel: [phone] Fax: [phone]

# 510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

**Identification:** Quickstick™ One Step HCG Pregnancy Test

**Description:** Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Pregnancy

**Manufacturer:** Phamatech
9265 Activity Road #112, San Diego, California 92126, USA

**Intended Use:** The Quickstick™ One Step HCG Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.

**Technology:** The Quickstick™ One Step HCG Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Unipath Clearview HCG (Mountainview, CA 94043), Abbott Laboratories’ Fact Plus (Abbott Park, IL 60064) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / HCG / antibody / complexes.

**Performance:** The product performance characteristics of the Quickstick™ One Step HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study. The results of these studies demonstrate the Phamatech Quickstick™ One Step HCG Pregnancy Test to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of early pregnancy. Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083). A blind labeled spiked consumer study was performed, the Phamatech Quickstick™ exhibited excellent sensitivity (79/79), specificity (79/79), and accuracy (158/158) in the hands of lay users.

**Conclusion:** For the reasons mentioned above, it may be concluded that the Phamatech Quickstick™ One Step HCG Pregnancy Test is substantially equivalent to a variety of pregnancy tests currently in commercial distribution.

page 1