Cleared Traditional

DSL CK-MB (DSL #3200) (K904721) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904721 · Diagnostic Systems Laboratories, Inc. · Toxicology device
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Dec 1990
Decision
56d
Days
Class 2
Risk

K904721 is an FDA 510(k) clearance for the DSL CK-MB (DSL #3200). Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on December 13, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1215 - the FDA toxicology device 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 Systems Laboratories, Inc. devices

Submission Details

510(k) Number K904721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1990
Decision Date December 13, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHT Chromatographic Separation, Cpk 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 Toxicology devices follow this clearance model.

Regulatory Peers - JHT Chromatographic Separation, Cpk Isoenzymes

All 20
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K904721.
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359 · Helena Laboratories · Apr 1993
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · Helena Laboratories · Feb 1990
TITAN GEL CPK ISOENZYME SYSTEM
K822124 · Helena Laboratories · Nov 1982
CK-MB
K771497 · Boehringer Mannheim Corp. · Aug 1977