Cleared Traditional

K895555 - MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)

K895555 is an FDA 510(k) clearance for MODIFIED HI CHEM AMYLASE REAGENT (PRODU..., manufactured by Hichem Diagnostics. The device is a Class 2 Chemistry device with product code CJA cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K895555 · Hichem Diagnostics · Chemistry device
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Dec 1989
Decision
107d
Days
Class 2
Risk

K895555 is an FDA 510(k) clearance for the MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129). Classified as Amyloclastic, Amylase (product code CJA), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 107 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hichem Diagnostics devices

FDA 510(k) Submission Details - K895555

510(k) Number K895555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1989
Decision Date December 22, 1989
Days to Decision 107 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
19d slower than avg
Panel avg: 88d · This submission: 107d
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 7
Devices cleared under the same product code (CJA) and FDA review panel - the closest regulatory comparables to K895555.
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
AMYLASE REAGENT CS-726
K844168 · Fisher Scientific Co., LLC · Nov 1984