ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT

K955353 · Tcpi, Inc. · JHI · Mar 19, 1996 · Clinical Chemistry

Device Facts

• Record ID: K955353
• Device Name: ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT
• Applicant: Tcpi, Inc.
• Product Code: JHI · Clinical Chemistry
• Decision Date: Mar 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum.

Device Story

Qualitative sandwich dye conjugate immunoassay; detects hCG in urine, serum, or plasma. Sample flows through absorbent strip; labeled antibody-dye conjugate binds hCG; complex captured by anti-hCG antibody in positive reaction zone; pink-rose band indicates hCG > 25 mIU/ml. Unbound conjugate binds in negative control zone to verify device function. Results available in < 5 minutes. Used in clinical settings; performed by healthcare professionals. Provides rapid pregnancy confirmation; aids clinical decision-making regarding patient care.

Clinical Evidence

Clinical trials compared diluent reagent plus One Step™ Pregnancy hCG strip against reference methods using 385 patient samples (urine and serum/plasma). Results showed 100% agreement with reference methods. Additional blind testing of 150 samples (90 pregnant, 60 non-pregnant) demonstrated 100% sensitivity and specificity (no false positives/negatives).

Technological Characteristics

Qualitative sandwich dye conjugate immunoassay; utilizes monoclonal and polyclonal antibodies; patented membrane technology; lateral flow absorbent strip; sensitivity threshold 25 mIU/ml.

Indications for Use

Indicated for the qualitative detection of Human Chorionic Gonadotropin (hCG) in urine, serum, or plasma to aid in the early detection of pregnancy.

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

• One Step™ Pregnancy hCG strip (K934830)

Submission Summary (Full Text)

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From: Dr. Cleve W. Laird To: Ann Hawthorne
Date: 2/29/96 Time: 09:56:04
Page 2 of 3
K95 5353
MAR 19 1996

# Summary of Safety and Effectiveness

This summary of safety and effectiveness was originally prepared by Technical Chemicals and Products Inc. for inclusion in its One Step™ Pregnancy hCG strip. This represents an expansion of the intended use to include both serum and plasma as well as urine. For any questions contact Dr. Cleve W. Laird, Exec. V.P., Technical Chemicals and Products Inc. at 954-971-7595. The Predicate device is One Step™ Pregnancy hCG strip a class II device cleared under 510K # 934830.

The Technical Chemicals and Products Inc. ("TCPI") One Step™ Pregnancy hCG strip assay is a qualitative, sandwich dye conjugate immunoassay for the determination of Human Chorionic Gonadotropin in urine or serum. The method employs a unique combination of monoclonal and polyclonal antibodies to selectively identify hCG in test samples with a high degree of sensitivity using a unique patented membrane technology. In less than 5 minutes, elevated levels of hCG as low as 25 mIU/ml can be detected. If the test is to be used on serum the sample must be diluted according to the directions for the One Step™ Pregnancy hCG serum diluent (cat XXXXX).

As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody in the positive reaction zone and produces a pink-rose color band when hCG concentration is greater than 25 mIU/ml. In the absence of hCG, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the positive reaction zone and negative zone. Unbound conjugate binds to the reagents in the negative control zone, producing a pink-rose (magenta) color band, demonstrating that the reagents and device are functioning correctly.

The TCPI One Step™ Pregnancy hCG strip hCG test has been extensively tested against substances known to interfere with pregnancy testing with no apparent interferences. The specificity of the reaction has been tested against other hormones with no cross reactivity noted. The sensitivity of the product is routinely tested and found to be 25 mIU/ml [See Stability testing]. When tested blind in 150 documented (Pregnant/not pregnant) patient samples the test correctly identified all 150 samples (90 pregnant and 60 not pregnant). There were no false negatives or positives. TCPI has produced and distributed in excess of 19,604,093 strips World wide for the past four (4) years with very few complaints. All of the complaints have been related to shipping problems between the foreign distributor and the retail outlets or not following the directions for use.

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From: Dr. Cleve W. Laird To: Ann Hawthorne
Date: 2/29/96 Time: 09:56:59
Page 3 of 3

In a series of clinical trials the combination of the diluent reagent and One Step™ Pregnancy hCG Strip were compared to reference methods and samples (urine and serum/plasma) In all 385 patient comparisons the results of the diluent reagent plus the One Step™ Pregnancy hCG strip agreed with the reference methods employed in the studies. Based upon the results of the clinical testing the accuracy, sensitivity, and specificity all equal 100%.