E.P.T. PREGNANCY TEST

K033658 · Unipath , Ltd. · LCX · Jan 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033658
• Device Name: E.P.T. PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jan 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

e.p.t.® Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test is indicated for use from first day of missed period and before the expected period.

Device Story

The e.p.t. Pregnancy Test is an over-the-counter, lateral flow immunoassay designed for home use by consumers to detect human chorionic gonadotropin (hCG) in urine. The device utilizes a test strip containing specific antibodies that bind to hCG if present in the urine sample. A visual color change on the test strip indicates a positive result, signifying pregnancy. The test is intended for early detection, usable from the first day of a missed period or earlier. It provides a qualitative result to assist the user in determining pregnancy status without requiring professional clinical intervention.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of device modifications.

Technological Characteristics

Lateral flow immunoassay; qualitative visual readout. Modifications include physical form factor changes (sampler, window shapes, splashguard). No changes to fundamental scientific technology.

Indications for Use

Indicated for the 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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K033658

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATIONS, including clearly labeled diagrams, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was to allow marketing under the brand name e.p.t. Pregnancy Test. The device modifications included: result readout, control line position, device sampler, device appearance and window shapes for consistency with the e.p.t. Pregnancy Test brand, and addition of a splashguard. Modifications were also made to the labeling to reflect the preferred style of the labeler.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance specifications.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modifications and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

Revised: 8/1/03