Cleared Traditional

K960367 - INCSTAR RUBELLA IGG ELISA ASSAY

K960367 is an FDA 510(k) clearance for INCSTAR RUBELLA IGG ELISA ASSAY, manufactured by Incstar Corp.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K960367 · Incstar Corp. · Microbiology device
Download Printable Device Report (PDF)
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Oct 1996
Decision
273d
Days
Class 2
Risk

K960367 is an FDA 510(k) clearance for the INCSTAR RUBELLA IGG ELISA ASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on October 24, 1996 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Incstar Corp. devices

FDA 510(k) Submission Details - K960367

510(k) Number K960367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1996
Decision Date October 24, 1996
Days to Decision 273 days
Submission Type Traditional
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
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFX Device Classification - Class 2, Special Controls

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 Microbiology devices follow this clearance model.

Regulatory Peers - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 79
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K960367.
IMMULITE RUBELLA IGG
K963613 · Diagnostic Products Corp. · Apr 1997
RUBASCAN CARD TEST
K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · Incstar Corp. · Oct 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · Abbott Laboratories · Sep 1996
SERAQUEST RUBELLA IGG
K961053 · Quest Intl., Inc. · Sep 1996
IMX RUBELLA IGG
K951541 · Abbott Laboratories · Jul 1996