Cleared Traditional

K860530 - AMYLASE REAGENT SET (MODIFIED CARAWAY)

K860530 is the FDA 510(k) clearance for AMYLASE REAGENT SET (MODIFIED CARAWAY) by Sterling Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CJA) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K860530 · Sterling Diagnostics, Inc. · Chemistry device
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Feb 1986
Decision
16d
Days
Class 2
Risk

K860530 is an FDA 510(k) clearance for the AMYLASE REAGENT SET (MODIFIED CARAWAY). Classified as Amyloclastic, Amylase (product code CJA), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 16 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K860530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1986
Decision Date February 28, 1986
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K860530.
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 CS-726
K844168 · Fisher Scientific Co., LLC · Nov 1984
ASTRA SYSTEMS AMYLASE REAGENT KIT
K843529 · Beckman Instruments, Inc. · Oct 1984