Clearblue® Early Detection Pregnancy Test

K240025 · Spd Swiss Precision Diagnostics GmbH · LCX · Jan 31, 2024 · Clinical Chemistry

Device Facts

• Record ID: K240025
• Device Name: Clearblue® Early Detection Pregnancy Test
• Applicant: Spd Swiss Precision Diagnostics GmbH
• Product Code: LCX · Clinical Chemistry
• Decision Date: Jan 31, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The Clearblue® Early Detection Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. The test is intended for home use.

Device Story

Clearblue® Early Detection Pregnancy Test is an over-the-counter, lateral flow chromatographic immunoassay. Device uses urine sample to detect human chorionic gonadotropin (hCG). Principle of operation relies on antibody-antigen binding; presence of hCG triggers visual indicator on test strip. Intended for home use by individuals for early pregnancy detection. User interprets visual results directly from test device. Provides qualitative result to aid in pregnancy confirmation; facilitates early clinical decision-making regarding prenatal care.

Clinical Evidence

No clinical data provided; substantial equivalence established via design control activities and verification of unchanged fundamental scientific technology following labeling and tradename modifications.

Technological Characteristics

Immunochromatographic lateral flow assay; qualitative detection of hCG in urine. Device consists of an absorbent test strip housed in a plastic casing. No electronic components, software, or external energy sources. Sterilization not applicable for this diagnostic test format.

Indications for Use

Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy 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.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K240025

B Applicant

SPD Swiss Precision Diagnostics GmbH

C Proprietary and Established Names

ClearBlue® Early Detection Pregnancy Test

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCX | Class II | 21 CFR 862.1155 - Human Chorionic Gonadotropin (HCG) Test System | CH - Clinical Chemistry |

## II Review Summary:

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: Clearblue ® Early Pregnancy Test, K213379.
2. Submitter's statement that the INDICATIONS FOR USE/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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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device has not changed. This change was for: changes to device tradename and labeling to harmonize different versions.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical 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.

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.

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