Cleared Traditional

LIQUID TDM CONTROLS (K871788) - FDA 510(k) Clearance

Class I Chemistry device.

K871788 · Biological Industries · Chemistry device
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Jun 1987
Decision
42d
Days
Class 1
Risk

K871788 is an FDA 510(k) clearance for the LIQUID TDM CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biological Industries (25115, IL). The FDA issued a Cleared decision on June 17, 1987 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - 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: 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 Biological Industries devices

Submission Details

510(k) Number K871788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1987
Decision Date June 17, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture 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 - DIF Drug Mixture Control Materials

All 78
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K871788.
TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS
K873183 · Abbott Laboratories · Nov 1987
ACA URINE DRUGS OF ABUSE CONTROL
K873539 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1987
CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL
K873037 · Diagnostic Products Corp. · Oct 1987
LYPHOCHEK URINE TOXICOLOGY CONTROL
K861970 · Bio-Rad · Aug 1986
THERAPEUTIC DRUG (TDM) CALIBRATOR
K860097 · Instrumentation Laboratory CO · Feb 1986
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414 · Bio-Rad · Jul 1985