Cleared Traditional

K031052 - CARESTART HCG ONE-STEP PREGNANCY TEST

K031052 is an FDA 510(k) clearance for CARESTART HCG ONE-STEP PREGNANCY TEST, manufactured by Access Bio Incorporate. The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K031052 · Access Bio Incorporate · Chemistry device
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Jun 2003
Decision
72d
Days
Class 2
Risk

K031052 is an FDA 510(k) clearance for the CARESTART HCG ONE-STEP PREGNANCY TEST. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Access Bio Incorporate (North Brunswick, US). The FDA issued a Cleared decision on June 13, 2003 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Access Bio Incorporate devices

FDA 510(k) Submission Details - K031052

510(k) Number K031052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2003
Decision Date June 13, 2003
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, Human Chorionic Gonadotropin
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 - DHA System, Test, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K031052.
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
K060548 · Dade Behring, Inc. · Apr 2006
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
K042676 · Nichols Institute Diagnostics · Dec 2004
IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER
K033234 · Diagnostic Products Corp. · Dec 2003
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD
K003696 · Dade Behring, Inc. · Jan 2001
ELECSYS HCG AND BETA TEST SYSTEM
K003178 · Roche Diagnostics Corp. · Dec 2000
ELECSYS HCG TEST SYSTEM
K002148 · Roche Diagnostics Corp. · Aug 2000