Cleared Special

MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (K982210) - FDA 510(k) Clearance

Class I Microbiology device.

K982210 · Dade Behring, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jul 1998
Decision
16d
Days
Class 1
Risk

K982210 is an FDA 510(k) clearance for the MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on July 9, 1998 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K982210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1998
Decision Date July 09, 1998
Days to Decision 16 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

All 66
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K982210.
IMX SELECT CHLAMYDIA
K936054 · Abbott Laboratories · May 1996
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090 · Syva Co. · Sep 1993
MICRO TRAK XL SYSTEM
K921747 · Syva Co. · Oct 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992
SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
K905179 · Syva Co. · Mar 1991