Cleared Traditional

K023780 - DRI PRIMIDONE CALIBRATORS

K023780 is an FDA 510(k) clearance for DRI PRIMIDONE CALIBRATORS, manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K023780

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.

DLJ Device Classification - Class 2, Special Controls

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 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K023780.
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