Cleared Traditional

K852483 - SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO....

K852483 is the FDA 510(k) clearance for SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO.... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CGS) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K852483 · Em Diagnostic Systems, Inc. · Chemistry device
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Jul 1985
Decision
31d
Days
Class 2
Risk

K852483 is an FDA 510(k) clearance for the SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205. Classified as Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (product code CGS), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 K852483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date July 12, 1985
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - CGS Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes

All 99
Devices cleared under the same product code (CGS) and FDA review panel - the closest regulatory comparables to K852483.
EMDS TOTAL CK TEST PACK-#67670/95
K855056 · Em Diagnostic Systems, Inc. · Jan 1986
CK(OPTIMIZED) REAGENT
K854501 · Sigma Diagnostics, Inc. · Dec 1985
EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE
K852392 · Helena Laboratories · Oct 1985
ISOENZYME TEST CK-MB
K850212 · Sclavo, Inc. · Feb 1985
TITAN GEL ISO DOT CPK PROCEDURE
K842755 · Helena Laboratories · Sep 1984
SYSTEMATE CK-TOTAL - 67206
K843271 · Em Diagnostic Systems, Inc. · Sep 1984