E.P.T. CERTAINTY 1-STEP PREGNANCY TEST

K061769 · Unipath , Ltd. · LCX · Jul 3, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061769
• Device Name: E.P.T. CERTAINTY 1-STEP PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

e.p.t Certainty® 1-Step 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 four days before the expected period.

Device Story

e.p.t Certainty® 1-Step Pregnancy Test is a lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine. Device intended for home use by lay individuals. User applies urine sample to test device; hCG, if present, binds to labeled antibodies, migrating along membrane to capture zone, producing visible line indicating pregnancy. Results provide early detection of pregnancy. Device aids in clinical decision-making by confirming pregnancy status, allowing users to seek appropriate prenatal care.

Clinical Evidence

No clinical data provided; device relies on analytical performance characteristics typical of lateral flow hCG immunoassays.

Technological Characteristics

Lateral flow immunoassay; qualitative hCG detection. Physical form factor modified (casing/cap). No changes to reagents or assay principle.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy in women.

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)

{0}

SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K061769
UNIPATH LTD. e.p.t. Certainty® 1-Step Pregnancy Test

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
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.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, 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 This modification is a change in the design of the device casing, cap and branding to allow marketing of the device under the band name "e.p.t. Certainty® 1-Step Pregnancy Test". The design of the labeling has also been modified to discriminate the device form Clearblue® Easy Digital Pregnancy Test. The e.p.t. Certainty® 1-Step Pregnancy Test will be distributed in the US by Pfizer Consumer Healthcare.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) 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) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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 modification(s) 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 (or their preamendment) device.