Cleared Traditional

K963673 - IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR

K963673 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code KLT cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K963673 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
144d
Days
Class 2
Risk

K963673 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS. 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 4, 1997 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3645 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K963673

510(k) Number K963673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1996
Decision Date February 04, 1997
Days to Decision 144 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 88d · This submission: 144d
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 Chemistry 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 K963673.
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS
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K993987 · Syva Co. · Jan 2000
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1998
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
K964068 · Bayer Corp. · Dec 1996
CARBAMAZEPINE FLEX REAGENT CARTRIDGE
K962820 · Dade Intl., Inc. · Sep 1996
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
K955644 · Beckman Instruments, Inc. · Feb 1996