Cleared Traditional

K023780 - DRI PRIMIDONE CALIBRATORS

K023780 is the FDA 510(k) clearance for DRI PRIMIDONE CALIBRATORS by Microgenics Corp.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K023780 · Microgenics Corp. · Toxicology device
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Feb 2003
Decision
90d
Days
Class 2
Risk

K023780 is an FDA 510(k) clearance for the DRI PRIMIDONE CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on February 10, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Microgenics Corp. devices

Submission Details

510(k) Number K023780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2002
Decision Date February 10, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K023780.
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K020845 · Dade Behring, Inc. · May 2002