Cleared Traditional

K790399 - URINE MEDIUM CALIBRATOR

K790399 is an FDA 510(k) clearance for URINE MEDIUM CALIBRATOR, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K790399 · Syva Co. · Toxicology device
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Jun 1979
Decision
109d
Days
Class 2
Risk

K790399 is an FDA 510(k) clearance for the URINE MEDIUM CALIBRATOR. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 109 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 Syva Co. devices

FDA 510(k) Submission Details - K790399

510(k) Number K790399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date June 15, 1979
Days to Decision 109 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 87d · This submission: 109d
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 K790399.
EMIT-ST SERUM PHENOBARBITAL CALIBRATOR
K811622 · Syva Co. · Jun 1981
EMIT -D.A.U. CANNABINOID URINE CALIBS.
K800247 · Syva Co. · Feb 1980
EMIT-D.A.U. PHENCYCLIDINE URINE LOW
K790398 · Syva Co. · Jun 1979
LIDOCAINE CALIBRATOR KIT
K780731 · Vitek Systems, Inc. · Jan 1979
PROCAINAMIDE CALIBRATOR KIT
K780732 · Vitek Systems, Inc. · Nov 1978
EMIT THEOPHYLLINE CONTROL
K772166 · Syva Co. · Nov 1977