Cleared Traditional

K881943 - EMIT HVA CALIBRATOR KIT

K881943 is the FDA 510(k) clearance for EMIT HVA CALIBRATOR KIT by Syva Co.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K881943 · Syva Co. · Toxicology device
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Jul 1988
Decision
60d
Days
Class 2
Risk

K881943 is an FDA 510(k) clearance for the EMIT HVA CALIBRATOR KIT. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on July 8, 1988 after a review of 60 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 K881943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1988
Decision Date July 08, 1988
Days to Decision 60 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
27d faster than avg
Panel avg: 87d · This submission: 60d
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 K881943.
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
K894934 · Hycor Biomedical, Inc. · Oct 1989
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
K893815 · Hycor Biomedical, Inc. · Jul 1989
DRUGS OF ABUSE URINE CALIBRATORS
K892332 · Hycor Biomedical, Inc. · May 1989
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