Cleared Traditional

K910881 - CONTROL AND LINEARITY

K910881 is an FDA 510(k) clearance for CONTROL AND LINEARITY, manufactured by Gds Diagnostics. The device is a Class 2 Chemistry device with product code DKB cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K910881 · Gds Diagnostics · Chemistry device
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Sep 1991
Decision
196d
Days
Class 2
Risk

K910881 is an FDA 510(k) clearance for the CONTROL AND LINEARITY. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Gds Diagnostics (Elkhart, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 196 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Gds Diagnostics devices

FDA 510(k) Submission Details - K910881

510(k) Number K910881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date September 13, 1991
Days to Decision 196 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKB Device Classification - Class 2, Special Controls

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 88
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K910881.
EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH)
K915003 · Syva Co. · Nov 1991
IL TEST(TM) DAT CAL/CONTROL SET B
K913740 · Instrumentation Laboratory CO · Oct 1991
IL TEST(TM) DAT CAL/CONTROL SET C
K913741 · Instrumentation Laboratory CO · Oct 1991
IL TEST(TM) DAT CALIBRATOR A( -)
K913739 · Instrumentation Laboratory CO · Sep 1991
ABUSCREEN(R) ONLINE(TM) CALIBRATORS
K913335 · Roche Diagnostic Systems, Inc. · Aug 1991
EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)
K912729 · Syva Co. · Jul 1991