Cleared Traditional

K883935 - ORTHO* ROTAVIRUS ANTIGEN ELISA TEST

K883935 is an FDA 510(k) clearance for ORTHO* ROTAVIRUS ANTIGEN ELISA TEST, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Microbiology device with product code LIQ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K883935 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Jan 1989
Decision
107d
Days
Class 1
Risk

K883935 is an FDA 510(k) clearance for the ORTHO* ROTAVIRUS ANTIGEN ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rotavirus (product code LIQ), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on January 4, 1989 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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 Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K883935

510(k) Number K883935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1988
Decision Date January 04, 1989
Days to Decision 107 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
5d slower than avg
Panel avg: 102d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

LIQ Device Classification - Class 1, General Controls

Product Code LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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 - LIQ Enzyme Linked Immunoabsorbent Assay, Rotavirus

All 27
Devices cleared under the same product code (LIQ) and FDA review panel - the closest regulatory comparables to K883935.
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · Dako Corp. · Feb 1992
SLIDEX ROTA-KIT 2
K895805 · Vitek Systems, Inc. · Feb 1991
ROTACUBE
K884017 · Difco Laboratories, Inc. · Jan 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · Ortho Diagnostic Systems, Inc. · Jan 1989
RESUBMITTED ABBOTT TESTPACK ROTAVIRUS
K880821 · Abbott Laboratories · May 1988
ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
K874375 · Abbott Laboratories · Dec 1987