Cleared Traditional

K031048 - CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST

K031048 is an FDA 510(k) clearance for CARESTART HCG COMBO ONE-STEP PREGNANCY ..., manufactured by Access Bio Incorporate. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K031048 · Access Bio Incorporate · Chemistry device
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Jun 2003
Decision
75d
Days
Class 2
Risk

K031048 is an FDA 510(k) clearance for the CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-.... Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Access Bio Incorporate (North Brunswick, US). The FDA issued a Cleared decision on June 16, 2003 after a review of 75 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 - K031048

510(k) Number K031048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2003
Decision Date June 16, 2003
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

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 Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 280
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K031048.
LIFESIGN DXPRESS, MODEL LSR2000
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ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc. · Aug 2004
CLINITEST HCG PREGNANCY TEST
K032563 · Bayer Healthcare, LLC · Dec 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · Bayer Corp. · Feb 2003
GENZYME CONTRAST II HCG URINE/SERUM TEST
K023544 · Genzyme Corp. · Jan 2003
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002