Cleared Traditional

K791994 - CREATININE DIAG. REAGENT PICRIC ACID

K791994 is the FDA 510(k) clearance for CREATININE DIAG. REAGENT PICRIC ACID by Connecticut Diagnostics, Ltd.. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K791994 · Connecticut Diagnostics, Ltd. · Chemistry device
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Oct 1979
Decision
14d
Days
Class 2
Risk

K791994 is an FDA 510(k) clearance for the CREATININE DIAG. REAGENT PICRIC ACID. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Connecticut Diagnostics, Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Connecticut Diagnostics, Ltd. devices

Submission Details

510(k) Number K791994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1979
Decision Date October 17, 1979
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 114
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K791994.
ELVI CREATININE
K792397 · Volu Sol Medical Industries · Dec 1979
ELVI CREATININ
K792402 · Volu Sol Medical Industries · Dec 1979
ELVI CREATININE
K792404 · Volu Sol Medical Industries · Dec 1979
ALKALINE BUFFER
K791688 · Hi Chem, Inc. · Sep 1979
PICRIC SOLUTION
K791689 · Hi Chem, Inc. · Sep 1979
REAGENT KIT, BAKERS DIAGNOSTIC
K790044 · J.T. Baker Chemical Co. · Feb 1979