CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST

K040341 · Unipath , Ltd. · LCX · Mar 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040341
• Device Name: CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
• Applicant: Unipath , Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Mar 8, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

Clearblue Easy Earliest Results 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

Clearblue Easy Earliest Results Pregnancy Test is an over-the-counter (OTC) lateral flow immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. Designed for home use by consumers to detect pregnancy as early as four days before the expected period. The device utilizes an immunochromatographic principle where urine sample migrates across a membrane containing anti-hCG antibodies; presence of hCG results in a visible line indicating a positive result. The test provides a rapid visual readout for the user to interpret. It serves as an early diagnostic tool for pregnancy, allowing for timely clinical or personal health decisions.

Clinical Evidence

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

Technological Characteristics

Lateral flow immunochromatographic assay; qualitative detection of hCG in urine; visual readout; OTC form factor.

Indications for Use

Indicated for the detection of pregnancy in urine for over-the-counter use, starting four days before the expected 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 K040341

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 primarily to introduce an absorbent sampler that changes color when urine has been applied to it. Other device modifications include the following: location of buffering reagents, modified moulding, control and test lines positions, sampling time reduction for dip procedure, 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.

(Reviewer's Signature)

(Date)

Comments

This modified device will continue to be distributed in the U.S. by Unipath Diagnostics Inc. as the Clearblue Easy® Earliest Result Pregnancy Test and will replace the currently marketed Clearblue Easy® Earliest Result Pregnancy Test.

revised:8/1/03

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REVISED:3/14/95

THE 510(K) DOCUMENTATION FORMS ARE AVAILABLE ON THE LAN UNDER 510(K) BOILERPLATES TITLED "DOCUMENTATION" AND MUST BE FILLED OUT WITH EVERY FINAL DECISION (SE, NSE, NOT A DEVICE, ETC.).

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

K _______________

Reviewer: _______________

Division/Branch: _______________

Device Name: _______________

Product To Which Compared (510(K) Number If Known): _______________

YES NO

| 1. Is Product A Device | | | If NO = Stop |
| --- | --- | --- | --- |
| 2. Is Device Subject To 510(k)? | | | If NO = Stop |
| 3. Same Indication Statement? | | | If YES = Go To 5 |
| 4. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness? | | | If YES = Stop NE |
| 5. Same Technological Characteristics? | | | If YES = Go To 7 |
| 6. Could The New Characteristics Affect Safety Or Effectiveness? | | | If YES = Go To 8 |
| 7. Descriptive Characteristics Precise Enough? | | | If NO = Go To 10
If YES = Stop SE |
| 8. New Types Of Safety Or Effectiveness Questions? | | | If YES = Stop NE |
| 9. Accepted Scientific Methods Exist? | | | If NO = Stop NE |
| 10. Performance Data Available? | | | If NO = Request Data |
| 11. Data Demonstrate Equivalence? | | | Final Decision: |

Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and 11, and every "no" response requires an explanation.

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1. Intended Use:

2. Device Description: Provide a statement of how the device is either similar to and/or different from other marketed devices, plus data (if necessary) to support the statement. Is the device life-supporting or life sustaining? Is the device implanted (short-term or long-term)? Does the device design use software? Is the device sterile? Is the device for single use? Is the device over-the-counter or prescription use? Does the device contain drug or biological product as a component? Is this device a kit? Provide a summary about the devices design, materials, physical properties and toxicology profile if important.

## EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED

1. Explain why not a device:
2. Explain why not subject to 510(k):
3. How does the new indication differ from the predicate device's indication:
4. Explain why there is or is not a new effect or safety or effectiveness issue:
5. Describe the new technological characteristics:
6. Explain how new characteristics could or could not affect safety or effectiveness:
7. Explain how descriptive characteristics are not precise enough:
8. Explain new types of safety or effectiveness questions raised or why the questions are not new:
9. Explain why existing scientific methods can not be used:
10. Explain what performance data is needed:
11. Explain how the performance data demonstrates that the device is or is not substantially equivalent:

ATTACH ADDITIONAL SUPPORTING INFORMATION

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