Cleared Traditional

K853244 - TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/...

K853244 is the FDA 510(k) clearance for TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/... by Simmler, Inc.. It is a Class 2 Chemistry device (product code CEK) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K853244 · Simmler, Inc. · Chemistry device
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Aug 1985
Decision
11d
Days
Class 2
Risk

K853244 is an FDA 510(k) clearance for the TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE. Classified as Biuret (colorimetric), Total Protein (product code CEK), Class II - Special Controls.

Submitted by Simmler, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 12, 1985 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 Simmler, Inc. devices

Submission Details

510(k) Number K853244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date August 12, 1985
Days to Decision 11 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 88d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEK Biuret (colorimetric), Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - CEK Biuret (colorimetric), Total Protein

All 79
Devices cleared under the same product code (CEK) and FDA review panel - the closest regulatory comparables to K853244.
QUANTIMETRIX BIURET SERUM TOTAL PROTEIN ASSAY KIT
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TOTAL PROTEIN
K854553 · American Monitor Corp. · Nov 1985
SIGMA 610 FOR PROTEIN IN URINE & CSF
K853681 · Sigma Diagnostics, Inc. · Oct 1985
AMRESCO FLOW PAC TOTAL PROTEIN BIURET & BLANK CONC
K852844 · American Research Products Co. · Jul 1985
TP BIURET REAGENT
K852006 · Alpkem Corp. · Jun 1985
TOTAL PROTEIN LIQUID STABLE REAGENT SET
K851877 · Medical Analysis Systems, Inc. · May 1985