Cleared Traditional

K843270 - SYSTEMATE ALKALINE PHOSPHATASE-67203

K843270 is the FDA 510(k) clearance for SYSTEMATE ALKALINE PHOSPHATASE-67203 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K843270 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1984
Decision
24d
Days
Class 2
Risk

K843270 is an FDA 510(k) clearance for the SYSTEMATE ALKALINE PHOSPHATASE-67203. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984 after a review of 24 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 K843270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date September 13, 1984
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 K843270.
IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN
K852441 · Clinical Data, Inc. · Aug 1985
AMRESCO FLOW PAC ALKALINE PHOSPHATASE BUFFER CONCE
K852752 · American Research Products Co. · Jul 1985
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110 · Abbott Laboratories · Jan 1985
ALKALINE PHOSPHATASE ASSAY KIT
K842243 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · Sigma Diagnostics, Inc. · Jun 1984
KINETIC ALKALINE PHOSPHATASE
K834033 · American Monitor Corp. · Jan 1984