Cleared Traditional

K993028 - ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS

Also marketed or referenced as:
MODELS 1E12 AND 6E90

K993028 is an FDA 510(k) clearance for ABBOTT AEROSET CARBAMAZEPINE ASSAY AND ..., manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K993028 · Syva Co. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
140d
Days
Class 2
Risk

K993028 is an FDA 510(k) clearance for the ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Syva Co. (San Jose, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3645 - 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 - K993028

510(k) Number K993028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1999
Decision Date January 27, 2000
Days to Decision 140 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
53d slower than avg
Panel avg: 87d · This submission: 140d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLT Enzyme Immunoassay, Carbamazepine

All 51
Devices cleared under the same product code (KLT) and FDA review panel - the closest regulatory comparables to K993028.
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229
K010814 · Syva Co., Dade Behring, Inc. · Apr 2001
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
K000903 · Bayer Corp. · May 2000
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6
K000007 · Diagnostic Products Corp. · Feb 2000
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL
K993987 · Syva Co. · Jan 2000
VITROS CHEMISTRY PRODUCTS CRBM SLIDES
K980283 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1998
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · Schiapparelli Biosystems, Inc. · Oct 1997