Cleared Traditional

K022409 - SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

K022409 is an FDA 510(k) clearance for SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST, manufactured by Spectral Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JHT cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K022409 · Spectral Diagnostics, Inc. · Chemistry device
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Sep 2002
Decision
68d
Days
Class 2
Risk

K022409 is an FDA 510(k) clearance for the SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST. Classified as Chromatographic Separation, Cpk Isoenzymes (product code JHT), Class II - Special Controls.

Submitted by Spectral Diagnostics, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on September 30, 2002 after a review of 68 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 Spectral Diagnostics, Inc. devices

FDA 510(k) Submission Details - K022409

510(k) Number K022409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2002
Decision Date September 30, 2002
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHT Device Classification - Class 2, Special Controls

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 Chemistry devices follow this clearance model.

Regulatory Peers - JHT Chromatographic Separation, Cpk Isoenzymes

All 18
Devices cleared under the same product code (JHT) and FDA review panel - the closest regulatory comparables to K022409.
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
K991299 · Princeton BioMeditech Corp. · May 1999
CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305
K930359 · Helena Laboratories · Apr 1993
DSL CK-MB (DSL #3200)
K904721 · Diagnostic Systems Laboratories, Inc. · Dec 1990
COULTER CK-MB ISOENZYME REAGENT
K904866 · Coulter Electronics, Inc. · Dec 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
K901450 · Intl. Immunoassay Laboratories, Inc. · May 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · Helena Laboratories · Feb 1990