Cleared Traditional

K844168 - AMYLASE REAGENT CS-726

K844168 is an FDA 510(k) clearance for AMYLASE REAGENT CS-726, manufactured by Fisher Scientific Co., LLC. The device is a Class 2 Chemistry device with product code CJA cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K844168 · Fisher Scientific Co., LLC · Chemistry device
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Nov 1984
Decision
26d
Days
Class 2
Risk

K844168 is an FDA 510(k) clearance for the AMYLASE REAGENT CS-726. Classified as Amyloclastic, Amylase (product code CJA), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Fair Lawn, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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.

FDA 510(k) Submission Details - K844168

510(k) Number K844168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1984
Decision Date November 20, 1984
Days to Decision 26 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
63d faster than avg
Panel avg: 89d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJA Device Classification - Class 2, Special Controls

Product Code CJA Amyloclastic, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CJA Amyloclastic, Amylase

All 9
Devices cleared under the same product code (CJA) and FDA review panel - the closest regulatory comparables to K844168.
AMYLASE LTS
K862640 · Electro-Nucleonics Laboratories, Inc. · Sep 1986
ALPHA AMYLASE
K863052 · J. D. Assoc. · Sep 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530 · Sterling Diagnostics, Inc. · Feb 1986
ASTRA SYSTEMS AMYLASE REAGENT KIT
K843529 · Beckman Instruments, Inc. · Oct 1984
AMYLASE REAGENT SET-MODIFIED CARAWAY
K833864 · Sterling Biochemical, Inc. · Jan 1984
K844168 · AMYLASE REAGENT CS-726
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