Cleared Traditional

K863842 - SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT

K863842 is an FDA 510(k) clearance for SERALYZER ARIS CARBAMAZEPINE STRIPS/MOD..., manufactured by Miles Laboratories, Inc.. The device is a Class 2 Toxicology device with product code KLT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K863842 · Miles Laboratories, Inc. · Toxicology device
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Jan 1987
Decision
105d
Days
Class 2
Risk

K863842 is an FDA 510(k) clearance for the SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT. Classified as Enzyme Immunoassay, Carbamazepine (product code KLT), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on January 14, 1987 after a review of 105 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 Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K863842

510(k) Number K863842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1986
Decision Date January 14, 1987
Days to Decision 105 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 87d · This submission: 105d
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 K863842.
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
K873282 · Windsor Laboratories, Inc. · Sep 1987
ACCULEVEL CARBAMAZEPINE TEST
K871254 · Syva Co. · Jun 1987
EMIT CARBAMAZEPINE ASSAY
K871306 · Syva Co. · Apr 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
K864553 · Em Diagnostic Systems, Inc. · Jan 1987
DETERMINATION OF CARBAMAZEPINE
K860047 · Clinical Data, Inc. · Jan 1986
EMIT QST CARBAMAZEPINE ASSAY
K853835 · Syva Co. · Oct 1985