Cleared Traditional

K993022 - SYNCHRON SYSTEMS OP 300 LOW AND HIGH UR...

K993022 is the FDA 510(k) clearance for SYNCHRON SYSTEMS OP 300 LOW AND HIGH UR... by Beckman Coulter, Inc.. It is a Class 2 Toxicology device (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

Submission Details

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.

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 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