Cleared Traditional

K821199 - CREATININE REAGENT SET

K821199 is an FDA 510(k) clearance for CREATININE REAGENT SET, manufactured by Omega Medical Electronics. The device is a Class 2 Chemistry device with product code CGX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K821199 · Omega Medical Electronics · Chemistry device
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Jul 1982
Decision
77d
Days
Class 2
Risk

K821199 is an FDA 510(k) clearance for the CREATININE REAGENT SET. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 77 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 Omega Medical Electronics devices

FDA 510(k) Submission Details - K821199

510(k) Number K821199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date July 13, 1982
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
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 K821199.
COBAS STANDARDS FOR CREATININE
K823572 · Hoffmann-La Roche, Inc. · Jan 1983
COBAS REAGENT FOR CREATININE
K823573 · Hoffmann-La Roche, Inc. · Jan 1983
ULTRACHEM CREA
K821881 · Harleco Diagnostics · Jul 1982
LIQUIZYME CREATININE REAGENT SET
K813560 · Amresco, Inc. · Jan 1982
SERALYZER CREATININE REAGENT STRIPS
K820075 · Miles Laboratories, Inc. · Jan 1982
CREATININE REAGENT SET
K812834 · Anco Medical Reagents & Assoc. · Dec 1981