Cleared Traditional

K213379 - Clearblue ® Early Pregnancy Test (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213379 · Spd Swiss Precision Diagnostics GmbH · Chemistry device
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Sep 2022
Decision
343d
Days
Class 2
Risk

K213379 is an FDA 510(k) clearance for the Clearblue ® Early Pregnancy Test. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Spd Swiss Precision Diagnostics GmbH (Geneva, CH). The FDA issued a Cleared decision on September 21, 2022 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Spd Swiss Precision Diagnostics GmbH devices

Submission Details

510(k) Number K213379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2021
Decision Date September 21, 2022
Days to Decision 343 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 88d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Consultant

SPD Development Company Limited
Kamila Przedmojska

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 225
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K213379.
MissLan® Early Detection Digital Pregnancy Test
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Shinetell PlusTM Digital Early Pregnancy Test
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FaStep Pregnancy Rapid Test Cassette
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Synthgene Home Test HCG Test Strip
K242135 · Nanjing Synthgene Medical Technology Co., Ltd. · Jan 2025
FaStep Early Pregnancy Rapid Test Strip
K243573 · Assure Tech., LLC · Jan 2025
iHealth® Early Pregnancy Test
K241394 · Andon Health Co, Ltd. · Dec 2024