Cleared Traditional

EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS (K862260) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862260 · Syva Co. · Toxicology device
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Nov 1986
Decision
143d
Days
Class 2
Risk

K862260 is an FDA 510(k) clearance for the EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on November 3, 1986 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - 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

Submission Details

510(k) Number K862260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date November 03, 1986
Days to Decision 143 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
56d slower than avg
Panel avg: 87d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCD Enzyme Immunoassay, Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 - LCD Enzyme Immunoassay, Gentamicin

All 36
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K862260.
ARCHITECT iGentamicin
K243500 · Abbott Laboratories · Jul 2025
ARCHITECT IGENTAMICIN REAGENTS
K102699 · Abbott Laboratories · Apr 2011
STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO.
K895484 · Baxter Healthcare Corp · Oct 1989
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY
K874703 · Syva Co. · Dec 1987
EMIT QST GENTAMICIN ASSAY
K873855 · Syva Co. · Oct 1987
EMIT GENTAMICIN ASSAY
K873854 · Syva Co. · Oct 1987