Cleared Traditional

K983971 - CARDIAC MARKER CONTROL MODULE

K983971 is the FDA 510(k) clearance for CARDIAC MARKER CONTROL MODULE by Diagnostic Products Corp.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K983971 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
9d
Days
Class 1
Risk

K983971 is an FDA 510(k) clearance for the CARDIAC MARKER CONTROL MODULE, MODEL CCCM. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K983971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date November 18, 1998
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 308
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K983971.
ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05
K984070 · Bio-Rad · Nov 1998
ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05
K984073 · Bio-Rad · Nov 1998
ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05
K984072 · Bio-Rad · Nov 1998
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578 · Bio-Rad · Nov 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471 · Boehringer Mannheim Corp. · Aug 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · Dade Behring, Inc. · Aug 1998