Cleared Traditional

K875216 - HIGH PERFORMANCE CALIBRATORS

K875216 is the FDA 510(k) clearance for HIGH PERFORMANCE CALIBRATORS by Rapid Diagnostic Laboratories, Inc.. It is a Class 2 Toxicology device (product code DKB) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K875216 · Rapid Diagnostic Laboratories, Inc. · Toxicology device
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Jun 1988
Decision
183d
Days
Class 2
Risk

K875216 is an FDA 510(k) clearance for the HIGH PERFORMANCE CALIBRATORS. Classified as Calibrators, Drug Mixture (product code DKB), Class II - Special Controls.

Submitted by Rapid Diagnostic Laboratories, Inc. (Port Washington, US). The FDA issued a Cleared decision on June 22, 1988 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rapid Diagnostic Laboratories, Inc. devices

Submission Details

510(k) Number K875216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date June 22, 1988
Days to Decision 183 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 87d · This submission: 183d
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 78
Devices cleared under the same product code (DKB) and FDA review panel - the closest regulatory comparables to K875216.
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K892332 · Hycor Biomedical, Inc. · May 1989
EMIT HVA CALIBRATOR KIT
K881943 · Syva Co. · Jul 1988
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