Cleared Traditional

EMIT IIC CALIBRATORS (K935192) - FDA 510(k) Clearance

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

K935192 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
514d
Days
Class 2
Risk

K935192 is an FDA 510(k) clearance for the EMIT IIC CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 514 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Syva Co. devices

Submission Details

510(k) Number K935192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1993
Decision Date March 24, 1995
Days to Decision 514 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
426d slower than avg
Panel avg: 88d · This submission: 514d
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 Chemistry 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 K935192.
EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5
K993755 · Syva Co. · Dec 1999
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
K915003 · Syva Co. · Nov 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
K912729 · Syva Co. · Jul 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