Cleared Traditional

K993715 - QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3

K993715 is an FDA 510(k) clearance for QUALITROL CARDIAC MARKER CONTROL, manufactured by Seracare Technology. The device is a Class 1 Immunology device with product code JJT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K993715 · Seracare Technology · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
13d
Days
Class 1
Risk

K993715 is an FDA 510(k) clearance for the QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Seracare Technology (Austin, US). The FDA issued a Cleared decision on November 16, 1999 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 Seracare Technology devices

FDA 510(k) Submission Details - K993715

510(k) Number K993715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1999
Decision Date November 16, 1999
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 105d · This submission: 13d
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 K993715.
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · Bio-Rad · May 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · Bio-Rad · Sep 2001
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · Quantimetrix Corp. · Nov 1999
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K992430 · Medical Analysis Systems, Inc. · Aug 1999
QUANTEX ASO-CRP-RP CONTROL II
K984437 · Instrumentation Laboratory CO · Feb 1999
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K984277 · Medical Analysis Systems, Inc. · Dec 1998