Cleared Traditional

K851865 - AMRESCO FLOW PAC SMA PHOSPHATE BUFFER C...

K851865 is the FDA 510(k) clearance for AMRESCO FLOW PAC SMA PHOSPHATE BUFFER C... by Amresco, Inc.. It is a Class 2 Chemistry device (product code CIT) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K851865 · Amresco, Inc. · Chemistry device
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May 1985
Decision
21d
Days
Class 2
Risk

K851865 is an FDA 510(k) clearance for the AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE. Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Amresco, Inc. (South Euclid, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 Amresco, Inc. devices

Submission Details

510(k) Number K851865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date May 20, 1985
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 107
Devices cleared under the same product code (CIT) and FDA review panel - the closest regulatory comparables to K851865.
VISION SGOT (AST)
K854982 · Abbott Laboratories · Jan 1986
AST(OPTIMIZED) REAGENT
K854503 · Sigma Diagnostics, Inc. · Nov 1985
AST ASPARTATE AMINOTRANSFERASE REAGENT
K851994 · Alpkem Corp. · Jun 1985
GEMENI AST-LTS REAGENTS
K851267 · Electro-Nucleonics Laboratories, Inc. · Apr 1985
ROCHE REAGENT FOR AST
K843109 · Roche Diagnostic Systems, Inc. · Nov 1984
SYSTEMATE GOT 67208
K843333 · Em Diagnostic Systems, Inc. · Sep 1984