Cleared Traditional

K230741 - Macro & Micro-Test HCG Pregnancy Test Midstream (FDA 510(k) Clearance)

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

K230741 · Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 2023
Decision
210d
Days
Class 2
Risk

K230741 is an FDA 510(k) clearance for the Macro & Micro-Test HCG Pregnancy Test Midstream. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on October 13, 2023 after a review of 210 days - an extended review cycle.

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. Standard predicate reliance. 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 Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. devices

Submission Details

510(k) Number K230741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2023
Decision Date October 13, 2023
Days to Decision 210 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
122d slower than avg
Panel avg: 88d · This submission: 210d
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

Shanghai Sungo Management Consulting Company Limited.
Sandra Jiang

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 K230741.
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FaStep Pregnancy Rapid Test Cassette
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Synthgene Home Test HCG Test Strip
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