Cleared Traditional

K790044 - REAGENT KIT, BAKERS DIAGNOSTIC

K790044 is an FDA 510(k) clearance for REAGENT KIT, manufactured by J.T. Baker Chemical Co.. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K790044 · J.T. Baker Chemical Co. · Chemistry device
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Feb 1979
Decision
48d
Days
Class 2
Risk

K790044 is an FDA 510(k) clearance for the REAGENT KIT, BAKERS DIAGNOSTIC. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on February 22, 1979 after a review of 48 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 J.T. Baker Chemical Co. devices

FDA 510(k) Submission Details - K790044

510(k) Number K790044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1979
Decision Date February 22, 1979
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGX Device Classification - Class 2, Special Controls

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 143
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K790044.
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
HILAR
K782094 · Hi Chem, Inc. · Jan 1979
SERUM, CREATININE DETERMINATIONS
K781884 · Fisher Scientific Co., LLC · Dec 1978
CREATININE REAGENT SET
K781396 · Nobel Scientific Industries, Inc. · Sep 1978