Cleared Traditional

K875210 - ALKALINE PHOSPHATASE CAT. # 306-22, 306-23

K875210 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE CAT. # 306-22, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K875210 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1988
Decision
46d
Days
Class 2
Risk

K875210 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE CAT. # 306-22, 306-23. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Monroe, US). The FDA issued a Cleared decision on February 2, 1988 after a review of 46 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. (Usa) devices

FDA 510(k) Submission Details - K875210

510(k) Number K875210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1987
Decision Date February 02, 1988
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
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 K875210.
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
K880795 · Trace America, Inc. · Apr 1988
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
K880796 · Trace America, Inc. · Apr 1988
ALKALINE PHOSPHATASE REAGENT SET
K880307 · Tech-Neal Scientific, Inc. · Mar 1988
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · Em Diagnostic Systems, Inc. · Oct 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K873761 · Simmler, Inc. · Oct 1987
WAKO(TM) AUTOKIT ALP
K873333 · Wako Chemicals USA, Inc. · Oct 1987