Cleared Traditional

Alltest Pregnancy Rapid Combo Test Cassette (K203272) - FDA 510(k) Clearance

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

K203272 · Hangzhou AllTest Biotech Co., Ltd. · Chemistry device
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Jan 2022
Decision
451d
Days
Class 2
Risk

K203272 is an FDA 510(k) clearance for the Alltest Pregnancy Rapid Combo Test Cassette. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Hangzhou AllTest Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on January 31, 2022 after a review of 451 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Hangzhou AllTest Biotech Co., Ltd. devices

Submission Details

510(k) Number K203272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2020
Decision Date January 31, 2022
Days to Decision 451 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
363d slower than avg
Panel avg: 88d · This submission: 451d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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

LSI International, Inc.
Joe Shia

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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 64
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K203272.
Innovita HCG Pregnancy Rapid Combo Test
K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · Aug 2024
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001