CLEARBLUE EASY EASY READ PREGNANCY TEST

K041404 · Unipath , Ltd. · LCX · Jun 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041404
• Device Name: CLEARBLUE EASY EASY READ PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jun 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a Clearbite Easy Easy Read Fregnancy. The test is indicated for use from three days before the expected period.

Device Story

Clearblue Easy Easy Read Pregnancy Test is an over-the-counter lateral flow immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine. Device intended for home use by consumers to detect pregnancy. User applies urine sample to absorbent tip; hCG, if present, binds to labeled antibodies; complex migrates to test zone; visual signal indicates presence of hCG. Results interpreted visually by user. Provides early detection capability starting three days before expected period. Benefits include convenient, rapid, and private pregnancy confirmation.

Clinical Evidence

Summary of urine conception cycles study provided to support the 3-day early detection claim. No further clinical data details provided.

Technological Characteristics

Lateral flow immunoassay; qualitative detection of hCG in urine; visual readout; over-the-counter home use format.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine for 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.

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 K 041404

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 (labeling changes are permitted as long as they do not affect the intended use).

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 for inclusion of a 3-day early detection claim to the labeling.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics and summary of urine conception cycles study. This product is the exact same product as the predicate except that the early 3-day claim is included in the labeling and packaging. The name has also changed from "Clearblue Easy Digital Pregnancy Test" to "Clearblue Easy Easy Read Pregnancy Test".

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 pre-amendment) device.