Cleared Traditional

K961828 - LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)

K961828 is an FDA 510(k) clearance for LIQUICHEK CARDIAC MARKERS CONTROL (CAT...., manufactured by Bio-Rad. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K961828 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
29d
Days
Class 1
Risk

K961828 is an FDA 510(k) clearance for the LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688). Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Bio-Rad (Anaheim, US). The FDA issued a Cleared decision on June 11, 1996 after a review of 29 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 Bio-Rad devices

FDA 510(k) Submission Details - K961828

510(k) Number K961828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date June 11, 1996
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme 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 - JJT Enzyme Controls (assayed And Unassayed)

All 80
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K961828.
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
K965169 · Specialized Assays, Inc. · Feb 1997
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
K965166 · Specialized Assays, Inc. · Feb 1997
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
K965168 · Specialized Assays, Inc. · Feb 1997
OPUS CK-MB & TOTAL CK CONTROLS
K960275 · Behring Diagnostics, Inc. · Apr 1996
LIQUID CARDIAC MARKER 1,2,3 ASSAYED
K960246 · Ciba Corning Diagnostics Corp. · Apr 1996
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
K950803 · Isolab, Inc. · Sep 1995