EPT CERTAINTY PREGNANCY TEST

K032939 · Unipath , Ltd. · LCX · Oct 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032939
• Device Name: EPT CERTAINTY PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Oct 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

EPT Certainty" M Pregnancy Test is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test has a sensitivity of 50mIU/ml hCG in urine, and can be used from the first day of the missed period.

Device Story

EPT Certainty™ Pregnancy Test; modified version of previously cleared device. Modifications limited to brand name, color, and reader aesthetics/cosmetic changes for brand consistency. Labeling updated to reflect design changes and own-labeler identity. Device functions as pregnancy test; intended use remains unchanged from predicate. Operated by consumer for home use.

Clinical Evidence

No clinical data; bench testing and design control verification/validation activities performed to confirm modifications did not impact device performance.

Technological Characteristics

Pregnancy test device; modifications limited to aesthetic/cosmetic design and branding. Fundamental scientific technology unchanged from predicate. No changes to sensing principle or materials.

Indications for Use

Indicated for the detection of pregnancy in urine for over-the-counter use by individuals starting from the first day of a missed period.

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 K032939

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 EPT Certainty™ Pregnancy Test. The device was modified with name, color, and reader aesthetics/cosmetic changes for consistency with the EPT brand. Modifications were also made to the labeling to reflect the design changes and to incorporate the identity and preferred style of the own-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.