Cleared Traditional

K071930 - ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C

K071930 is an FDA 510(k) clearance for ONE STEP HCG URINE PREGNANCY TEST (STRIP), manufactured by Blue Cross Bio-Medical Co., Ltd.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K071930 · Blue Cross Bio-Medical Co., Ltd. · Chemistry device
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Dec 2007
Decision
158d
Days
Class 2
Risk

K071930 is an FDA 510(k) clearance for the ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PR.... Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Blue Cross Bio-Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 18, 2007 after a review of 158 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.

FDA 510(k) Submission Details - K071930

510(k) Number K071930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date December 18, 2007
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

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

All 221
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K071930.
CLEARBLUE EASY PREGNANCY TEST
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K081150 · Turklab Medical Devices, Inc. · Jun 2009
FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)
K083716 · Church & Dwight Co., Inc. · Jun 2009
ONE STEP HCG PREGNANCY TEST
K062703 · Ai DE Diagnostic Co., Ltd. · Jul 2007
KOREAMEDICO CHEXTIC HCG URINE PREGNANCY TEST
K062096 · Koreamedico Co. , Ltd. · May 2007
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST
K070054 · Church & Dwight Co., Inc. · May 2007
K071930 · ONE STEP HCG URINE PREGNANCY TEST (STRIP), MODEL B01-S, ONE STEP HCG URINE PREGNANCY TEST (CASSETTE) , MODEL B01C
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