Cleared Traditional

K914696 - MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011

K914696 is an FDA 510(k) clearance for MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST..., manufactured by Medix Biotech, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K914696 · Medix Biotech, Inc. · Chemistry device
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Nov 1991
Decision
26d
Days
Class 2
Risk

K914696 is an FDA 510(k) clearance for the MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011. 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 November 13, 1991 after a review of 26 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

FDA 510(k) Submission Details - K914696

510(k) Number K914696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1991
Decision Date November 13, 1991
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
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 288
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K914696.
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