Cleared Traditional

K003093 - ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30

K003093 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE-SL ASSAY, manufactured by Diagnostic Chemicals , Ltd.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K003093 · Diagnostic Chemicals , Ltd. · Chemistry device
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Nov 2000
Decision
55d
Days
Class 2
Risk

K003093 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on November 27, 2000 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Diagnostic Chemicals , Ltd. devices

FDA 510(k) Submission Details - K003093

510(k) Number K003093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date November 27, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K003093.
MODIFICATION TO ALKP
K023807 · Abbott Laboratories · Dec 2002
WIENER LAB. ALP 405
K013983 · Wiener Laboratories Saic · Jan 2002
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · Jas Diagnostics, Inc. · Jul 2001
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · Teco Diagnostics · Jan 2000
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762 · A.P. Total Care, Inc. · Sep 1999
ELAN ALKALINE PHOSPHATE REAGENT KIT
K991387 · Elan Holdings, Inc. · May 1999