Cleared Traditional

K864456 - CYCLOSPORIN A (WHOLE BLOOD) CONTROL - L...

K864456 is the FDA 510(k) clearance for CYCLOSPORIN A (WHOLE BLOOD) CONTROL - L... by Cala Diagnostics. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K864456 · Cala Diagnostics · Toxicology device
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May 1987
Decision
174d
Days
Class 1
Risk

K864456 is an FDA 510(k) clearance for the CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Cala Diagnostics (Los Osos, US). The FDA issued a Cleared decision on May 6, 1987 after a review of 174 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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 Cala Diagnostics devices

Submission Details

510(k) Number K864456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1986
Decision Date May 06, 1987
Days to Decision 174 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 87d · This submission: 174d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 56
Devices cleared under the same product code (LAS) and FDA review panel - the closest regulatory comparables to K864456.
DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER
K883891 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1988
DIGOXIN FPIA CONTROLS
K872347 · Sigma Diagnostics, Inc. · Jul 1987
PHENYTOIN FPIA CONTROLS
K871567 · Sigma Diagnostics, Inc. · Jul 1987
EMIT 700 CANNABINOID CONTROL SET
K843419 · Syva Co. · Oct 1984
ACA TRICYCLIC ANTIDEPRESSANTS SCREEN
K841533 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO
K831979 · Syva Co. · Jul 1983