Cleared Traditional

K993022 - SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS

K993022 is an FDA 510(k) clearance for SYNCHRON SYSTEMS OP 300 LOW AND HIGH UR..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K993022 · Beckman Coulter, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
61d
Days
Class 2
Risk

K993022 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 61 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K993022

510(k) Number K993022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date November 09, 1999
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 87d · This submission: 61d
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 K993022.
DRI ECSTASY URINE CALIBRATORS
K012109 · Microgenics Corp. · Aug 2001
CYCLOSPORINE CALIBRATOR
K011112 · Dade Behring, Inc. · Jul 2001
SYNCHRON SYSTEMS DRUG CALIBRATOR 2
K993473 · Beckman Coulter, Inc. · Nov 1999
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
K983555 · Roche Diagnostic Systems, Inc. · Dec 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
K983556 · Roche Diagnostic Systems, Inc. · Dec 1998
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K981926 · Emd Chemicals, Inc. · Jul 1998