Cleared Traditional

K895250 - SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM...

K895250 is the FDA 510(k) clearance for SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K895250 · Em Diagnostic Systems, Inc. · Chemistry device
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Oct 1989
Decision
71d
Days
Class 2
Risk

K895250 is an FDA 510(k) clearance for the SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 71 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K895250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1989
Decision Date October 31, 1989
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 83
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K895250.
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · Roche Diagnostic Systems, Inc. · Jul 1990
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
K900250 · American Research Products Co. · Mar 1990
COULTER ALP (ALK PHOS) REAGENT
K900216 · Coulter Corp. · Feb 1990
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