Cleared Traditional

K862260 - EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS

K862260 is an FDA 510(k) clearance for EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CON..., manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code LCD cleared through the Traditional 510(k) pathway after a 143-day FDA review.

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

FDA 510(k) Submission Details - K862260

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.

LCD Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K862260.
EMIT QST GENTAMICIN ASSAY
K873855 · Syva Co. · Oct 1987
EMIT GENTAMICIN ASSAY
K873854 · Syva Co. · Oct 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
K871329 · Em Diagnostic Systems, Inc. · May 1987
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN
K860868 · Technicon Instruments Corp. · Apr 1986
DETERMINATION OF GENTAMICIN
K860045 · Clinical Data, Inc. · Jan 1986
ACA GENTAMICIN TEST PACK
K852672 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1985