Cleared Traditional

K884226 - AMYLASE REAGENT KIT FOR ASTRA SYSTEMS

K884226 is an FDA 510(k) clearance for AMYLASE REAGENT KIT FOR ASTRA SYSTEMS, manufactured by A-Kem, Inc.. The device is a Class 2 Chemistry device with product code CJA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K884226 · A-Kem, Inc. · Chemistry device
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Dec 1988
Decision
64d
Days
Class 2
Risk

K884226 is an FDA 510(k) clearance for the AMYLASE REAGENT KIT FOR ASTRA SYSTEMS. Classified as Amyloclastic, Amylase (product code CJA), Class II - Special Controls.

Submitted by A-Kem, Inc. (Clifton, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 64 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.

View all A-Kem, Inc. devices

FDA 510(k) Submission Details - K884226

510(k) Number K884226 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 09, 1988
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 8
Devices cleared under the same product code (CJA) and FDA review panel - the closest regulatory comparables to K884226.
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · Hichem Diagnostics · Dec 1989
WAKO(TM) AUTOKIT AMYLASE
K883059 · Wako Chemicals USA, Inc. · Aug 1988
PARAMAX AMYLASE REAGENT
K873520 · Baxter Healthcare Corp · Nov 1987
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