Cleared Traditional

K932662 - CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDI...

K932662 is the FDA 510(k) clearance for CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDI... by More Diagnostics. It is a Class 1 Toxicology device (product code LAS) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K932662 · More Diagnostics · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
54d
Days
Class 1
Risk

K932662 is an FDA 510(k) clearance for the CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVEL. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on July 26, 1993 after a review of 54 days - a notably fast clearance 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: 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 More Diagnostics devices

Submission Details

510(k) Number K932662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date July 26, 1993
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 87d · This submission: 54d
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 K932662.
MICROGENICS THC CONTROL SETS
K943048 · Microgenics Corp. · Aug 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · Roche Diagnostic Systems, Inc. · Jan 1994
DUPONT ACA URINE METHADONE CONTROL
K934145 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1993
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
K921939 · Heraeus Kulzer, Inc. · Jul 1992
CANNABINOID URINE CONTROLS
K921141 · Diagnostic Reagents, Inc. · Apr 1992
ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL
K915516 · Roche Diagnostic Systems, Inc. · Jan 1992