Cleared Traditional

K972835 - 50NG/ML COCAINE METABOLITE CALIBRATOR

K972835 is an FDA 510(k) clearance for 50NG/ML COCAINE METABOLITE CALIBRATOR, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K972835 · Diagnostic Reagents, Inc. · Toxicology device
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Aug 1997
Decision
28d
Days
Class 2
Risk

K972835 is an FDA 510(k) clearance for the 50NG/ML COCAINE METABOLITE CALIBRATOR. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on August 28, 1997 after a review of 28 days - a notably fast clearance cycle.

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: 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 Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K972835

510(k) Number K972835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1997
Decision Date August 28, 1997
Days to Decision 28 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
59d faster than avg
Panel avg: 87d · This submission: 28d
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 104
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K972835.
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CEDIA DIGOXIN CALIBRATORS
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K962280 · Roche Diagnostic Systems, Inc. · Aug 1996
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K961726 · Roche Diagnostic Systems, Inc. · Jul 1996