Cleared Traditional

K915197 - PRECISE TM HCG

K915197 is an FDA 510(k) clearance for PRECISE TM HCG, manufactured by Becton Dickinson Advanced Diagnostics. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K915197 · Becton Dickinson Advanced Diagnostics · Chemistry device
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Dec 1991
Decision
28d
Days
Class 2
Risk

K915197 is an FDA 510(k) clearance for the PRECISE TM HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Becton Dickinson Advanced Diagnostics (Cockeysville, US). The FDA issued a Cleared decision on December 17, 1991 after a review of 28 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 Becton Dickinson Advanced Diagnostics devices

FDA 510(k) Submission Details - K915197

510(k) Number K915197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date December 17, 1991
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
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 294
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K915197.
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
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MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
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CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · Unipath , Ltd. · Oct 1991
TARGET(TM)-HOG
K914303 · V-Tech, Inc. · Oct 1991