Cleared Traditional

ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL (K830049) - FDA 510(k) Clearance

Class I Chemistry device.

K830049 · Syva Co. · Chemistry device
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Jan 1983
Decision
18d
Days
Class 1
Risk

K830049 is an FDA 510(k) clearance for the ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1983 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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 Syva Co. devices

Submission Details

510(k) Number K830049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1983
Decision Date January 28, 1983
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - LAS Drug Specific Control Materials

All 82
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K830049.
LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2
K910829 · Bio-Rad · Apr 1991
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004 · Bio-Rad · Apr 1989
EMIT 700 CANNABINOID CONTROL SET
K843419 · Syva Co. · Oct 1984
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979 · Syva Co. · Jul 1983
EMIT QST TOBRAMYCIN CONTROL
K831417 · Syva Co. · Jun 1983
ADVANCE EMIT(R) & TM AMIKACIN CONTROL
K823369 · Syva Co. · Dec 1982