Cleared Traditional

K920253 - MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TE...

K920253 is the FDA 510(k) clearance for MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TE... by Medix Biotech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K920253 · Medix Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
24d
Days
Class 2
Risk

K920253 is an FDA 510(k) clearance for the MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Medix Biotech, Inc. (Foster City, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 24 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 Medix Biotech, Inc. devices

Submission Details

510(k) Number K920253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1992
Decision Date February 14, 1992
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K920253.
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · Vitek Systems, Inc. · Jul 1992
AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR
K920505 · Eastman Kodak Company · Mar 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