Cleared Traditional

K853978 - TDX AMYLASE

K853978 is an FDA 510(k) clearance for TDX AMYLASE, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K853978 · Abbott Laboratories · Chemistry device
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Oct 1985
Decision
19d
Days
Class 2
Risk

K853978 is an FDA 510(k) clearance for the TDX AMYLASE. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 15, 1985 after a review of 19 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K853978

510(k) Number K853978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1985
Decision Date October 15, 1985
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K853978.
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · Amresco, Inc. · Mar 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340 · Sterling Diagnostics, Inc. · Feb 1986
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · Clinical Data, Inc. · Nov 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