Cleared Traditional

K853049 - ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/R...

K853049 is the FDA 510(k) clearance for ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/R... by Simmler, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K853049 · Simmler, Inc. · Chemistry device
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Aug 1985
Decision
14d
Days
Class 2
Risk

K853049 is an FDA 510(k) clearance for the ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Simmler, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 2, 1985 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 K853049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date August 02, 1985
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 CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 79
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K853049.
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · Clinical Data, Inc. · Nov 1985
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · Medical Analysis Systems, Inc. · Sep 1985
ALB BCG REAGENT
K852007 · Alpkem Corp. · May 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · Technicon Instruments Corp. · Apr 1985
ALBUMIN ASSAY KIT
K843104 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984