Cleared Traditional

VIGIL TDM CONTROLS (K972819) - FDA 510(k) Clearance

Class I Toxicology device.

K972819 · Beckman Instruments, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
15d
Days
Class 1
Risk

K972819 is an FDA 510(k) clearance for the VIGIL TDM CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 13, 1997 after a review of 15 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K972819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1997
Decision Date August 13, 1997
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
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 80
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K972819.
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · Roche Diagnostic Systems, Inc. · Oct 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
K981590 · Bio-Rad · Jun 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · Bio-Rad · Apr 1998
PRECINORM TDM CONTROLS
K971060 · Boehringer Mannheim Corp. · Jul 1997
LYPHOCHEK REMEDI CONTROL
K972174 · Bio-Rad · Jun 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691 · Bio-Rad · May 1997