Cleared Traditional

K875210 - ALKALINE PHOSPHATASE CAT. # 306-22

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

K875210 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 84
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K875210.
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · Abbott Laboratories · Mar 1989
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · Em Diagnostic Systems, Inc. · Nov 1988
BIOTROL ALKALINE PHOSPHATASE
K881742 · Biotrol, USA, Inc. · Jul 1988
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · Em Diagnostic Systems, Inc. · Oct 1987
WAKO(TM) AUTOKIT ALP
K873333 · Wako Chemicals USA, Inc. · Oct 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · Em Diagnostic Systems, Inc. · Sep 1987