Cleared Traditional

K873183 - TDXR MULTICONSTIT. CONTROLS FOR ABUSED ...

K873183 is an FDA 510(k) clearance for TDXR MULTICONSTIT. CONTROLS FOR ABUSED ..., manufactured by Abbott Laboratories. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K873183 · Abbott Laboratories · Toxicology device
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Nov 1987
Decision
103d
Days
Class 1
Risk

K873183 is an FDA 510(k) clearance for the TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 103 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

FDA 510(k) Submission Details - K873183

510(k) Number K873183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1987
Decision Date November 23, 1987
Days to Decision 103 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 87d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 150
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K873183.
LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
K880445 · Bio-Rad · Apr 1988
LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE
K880444 · Bio-Rad · Feb 1988
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III
K874757 · Baxter Healthcare Corp · Feb 1988
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
TDCONTROL LIQUID MULTI-ANALYTE THERAPEUTIC DRUG
K870586 · Medical Analysis Systems, Inc. · Apr 1987