Cleared Traditional

K892202 - DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG ...

K892202 is the FDA 510(k) clearance for DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG ... by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K892202 · Gull Laboratories, Inc. · Microbiology device
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Sep 1989
Decision
163d
Days
Class 2
Risk

K892202 is an FDA 510(k) clearance for the DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 13, 1989 after a review of 163 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 Gull Laboratories, Inc. devices

Submission Details

510(k) Number K892202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date September 13, 1989
Days to Decision 163 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 102d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K892202.
RUBELLA IGG ELISA TEST
K901635 · Gull Laboratories, Inc. · Jun 1990
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · Ortho Diagnostic Systems, Inc. · Dec 1989
PLATELIA RUBELLA IGG KIT
K894946 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
BIOTROL RUB-E.I.A. TEST G
K894544 · Biotrol, USA, Inc. · Aug 1989
RUBELLA ELISA TEST SYSTEM
K891783 · Zeus Scientific, Inc. · Aug 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · Abbott Laboratories · Jun 1989