← Product Code [LCX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX) · K042280

# FACT PLUS ONE-STEP PREGNANCY TEST KIT (K042280)

_Unipath , Ltd. · LCX · Sep 10, 2004 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K042280

## Device Facts

- **Applicant:** Unipath , Ltd.
- **Product Code:** [LCX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX.md)
- **Decision Date:** Sep 10, 2004
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1155
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

Fact plus® One-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

Fact plus® One-Step Pregnancy Test; lateral flow immunoassay for qualitative detection of hCG in urine; modified version of previously cleared device; cosmetic changes; absorbent sampler replaced with non-color-changing sampler; relocated buffering reagents; adjusted dipping time; modified control line position; added desiccant tablet; altered window shapes; intended for home use; provides visual result to user; aids in pregnancy determination.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Lateral flow immunoassay; utilizes absorbent sampler, buffering reagents, and control line; includes desiccant tablet; modified physical form factor and window design; fundamental scientific technology unchanged from predicate.

## Regulatory 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 K042280

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.

Modifications have been made primarily to make the cosmetic appearance of the device similar to the currently marketed Fact plus® test. The absorbent sampler that changes color when urine is applied to it has been replaced with a sampler that does not change color. Other changes include the following: location of buffering reagents, increased dipping time, control line position, inclusion of desiccant tablet in the test, window shapes, and corresponding labeling.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, reagents and materials used to manufacture the test's functional components, 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.

This modified device will be distributed in the U.S. by Unipath Diagnostics Inc. as the Fact plus® One-Step Pregnancy Test.

revised:8/1/03

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K042280](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/LCX/K042280)

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