Cleared Traditional

K915200 - PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA

K915200 is an FDA 510(k) clearance for PRECISE TM HCG FOR USE IN THE PHYSICIAN..., 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 27-day FDA review.

K915200 · Becton Dickinson Advanced Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
27d
Days
Class 2
Risk

K915200 is an FDA 510(k) clearance for the PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA. 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 16, 1991 after a review of 27 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 - K915200

510(k) Number K915200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date December 16, 1991
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K915200.
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · Eastman Kodak Company · Mar 1992
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · Medix Biotech, Inc. · Feb 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · Eastman Kodak Company · Jan 1992
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
K914696 · Medix Biotech, Inc. · Nov 1991
CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF
K914240 · Unipath , Ltd. · Oct 1991
TARGET(TM)-HOG
K914303 · V-Tech, Inc. · Oct 1991