Cleared Traditional

K800219 - SERUM CREATININE

Also marketed or referenced as:
ALK. BUFFER & PICRIC

K800219 is the FDA 510(k) clearance for SERUM CREATININE by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code CGX) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K800219 · Fisher Scientific Co., LLC · Chemistry device
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Feb 1980
Decision
22d
Days
Class 2
Risk

K800219 is an FDA 510(k) clearance for the SERUM CREATININE. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on February 26, 1980 after a review of 22 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K800219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1980
Decision Date February 26, 1980
Days to Decision 22 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
66d faster than avg
Panel avg: 88d · This submission: 22d
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 110
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K800219.
CREATININE REAGENT
K811659 · Gilford Diagnostics · Jun 1981
CREATININE TEST
K811664 · King Diagnostics, Inc. · Jun 1981
LANCER CREATININE MICROSAMPLE STAT ANA
K803087 · Sherwood Medical Co. · Jan 1981
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