Cleared Traditional

K955644 - SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM

K955644 is an FDA 510(k) clearance for SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code KLT cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K955644 · Beckman Instruments, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
66d
Days
Class 2
Risk

K955644 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3645 - the FDA immunology 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 Instruments, Inc. devices

FDA 510(k) Submission Details - K955644

510(k) Number K955644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date February 16, 1996
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 104d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLT Device Classification - Class 2, Special Controls

Product Code KLT Enzyme Immunoassay, Carbamazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3645
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 Immunology devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 45
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K955644.
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · Beckman Instruments, Inc. · Feb 1997
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068 · Bayer Corp. · Dec 1996
CARBAMAZEPINE FLEX REAGENT CARTRIDGE
K962820 · Dade Intl., Inc. · Sep 1996
CARBAMAZEPINE EIA TEST
K955100 · Diagnostic Reagents, Inc. · Dec 1995
IL TEST CARBAMAZEPINE, PN 181754-00
K942687 · Instrumentation Laboratory CO · Jan 1995
AXSYM CARBAMAZEPHINE
K935374 · Abbott Laboratories · Jun 1994