Cleared Traditional

K842816 - EMIT D.A.U. LOW & MED. CALIBRATORS B

K842816 is the FDA 510(k) clearance for EMIT D.A.U. LOW & MED. CALIBRATORS B by Syva Co.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K842816 · Syva Co. · Toxicology device
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Sep 1984
Decision
49d
Days
Class 2
Risk

K842816 is an FDA 510(k) clearance for the EMIT D.A.U. LOW & MED. CALIBRATORS B. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology 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 Syva Co. devices

Submission Details

510(k) Number K842816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1984
Decision Date September 05, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 87d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKB Calibrators, Drug Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DKB Calibrators, Drug Mixture

All 77
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K842816.
ACA URINE DRUGS OF ABUSE CALIBRATOR
K872392 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1987
EMIT 700 CALIBRATOR B
K843507 · Syva Co. · Sep 1984
EMIT 700 CALIBRATOR A
K843163 · Syva Co. · Sep 1984
ACA BARBITURATES SCREEN/BENZODIAZEPIN
K842386 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
THERAPEUTIC DRUG CONTROL
K833761 · Icl Scientific · Jan 1984
ADVANCE SYSTEM EMITAED ANTIEPILEPTIC
K823740 · Syva Co. · Jan 1983