CLEARBLUE EASY PREGNANCY TEST

K110433 · SPD Development Company Limited · LCX · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110433
• Device Name: CLEARBLUE EASY PREGNANCY TEST
• Applicant: SPD Development Company Limited
• Product Code: LCX · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

Clearblue® Plus 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 (5 days before the missed period).

Device Story

Rapid, visually read, in vitro diagnostic immunoassay; detects hCG in urine; indicates pregnancy. Modifications: wick dimensions increased for easier midstream sampling; read time extended from 2 to 3 minutes; anti-flood pad added to mitigate excessive urine application; scavenger antibody added to reduce non-specific binding to latex particles; housing and window shapes modified; result key enlarged. Device used by consumers for home pregnancy testing. Output: visual result in window. Benefit: early pregnancy detection.

Clinical Evidence

No clinical data provided; device relies on bench testing to demonstrate analytical performance and substantial equivalence to the predicate.

Technological Characteristics

Lateral flow immunoassay; qualitative detection of hCG in urine. Device utilizes antibody-antigen binding principle. Form factor is a handheld test stick. No electronic components, software, or connectivity. Sterilization not applicable for this diagnostic test type.

Indications for Use

Indicated for qualitative detection of hCG in urine for early pregnancy detection 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.

Predicate Devices

• Clearblue Easy Pregnancy Test (K081635)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k110433

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).

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.) Clearblue Easy Earliest Results Pregnancy Test (k040341)

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:
- Change to dimensions of wick to facilitated easier midstream urine sampling
- Change read time from 2 to 3 minutes.
- Addition of anti-flood pad to minimize effects of excessive urine applied to device
- Addition of non-specific antibody ("scavenger antibody") to reduce potential for non-specific binding of sample to latex particles within the device
- Modified plastic housing
- Modified shape of result and control windows
- Larger result key on device

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics.

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.