Cleared Traditional

EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) (K912729) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912729 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
32d
Days
Class 2
Risk

K912729 is an FDA 510(k) clearance for the EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH). 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 22, 1991 after a review of 32 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 K912729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1991
Decision Date July 22, 1991
Days to Decision 32 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 87d · This submission: 32d
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 93
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K912729.
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · Syva Co. · Dec 1999
EMIT IIC CALIBRATORS
K935192 · Syva Co. · Mar 1995
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
K915003 · Syva Co. · Nov 1991
EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH)
K904764 · Syva Co. · Nov 1990
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
K903152 · Syva Co. · Aug 1990
EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)
K902581 · Syva Co. · Jul 1990