Cleared Traditional

K971060 - PRECINORM TDM CONTROLS

K971060 is an FDA 510(k) clearance for PRECINORM TDM CONTROLS, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K971060 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
105d
Days
Class 1
Risk

K971060 is an FDA 510(k) clearance for the PRECINORM TDM CONTROLS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 7, 1997 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K971060

510(k) Number K971060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1997
Decision Date July 07, 1997
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
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 148
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K971060.
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
VIGIL TDM CONTROLS
K972819 · Beckman Instruments, Inc. · Aug 1997
LYPHOCHEK REMEDI CONTROL
K972174 · Bio-Rad · Jun 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691 · Bio-Rad · May 1997
DOA-XSE, LIQUID DRUGS OF ABUSE CONTROL LEVELS 2,3, AND 4 (SDOA- 202,303,404)
K971058 · Medical Analysis Systems, Inc. · Apr 1997