Cleared Traditional

K900974 - INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.

K900974 is an FDA 510(k) clearance for INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA..., manufactured by Stellar Bio Systems, Inc.. The device is a Class 1 Microbiology device with product code JRY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K900974 · Stellar Bio Systems, Inc. · Microbiology device
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Apr 1990
Decision
45d
Days
Class 1
Risk

K900974 is an FDA 510(k) clearance for the INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.. Classified as Antiserum, Fluorescent, Epstein-barr Virus (product code JRY), Class I - General Controls.

Submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K900974

510(k) Number K900974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date April 16, 1990
Days to Decision 45 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
57d faster than avg
Panel avg: 102d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

JRY Device Classification - Class 1, General Controls

Product Code JRY Antiserum, Fluorescent, Epstein-barr Virus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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 - JRY Antiserum, Fluorescent, Epstein-barr Virus

All 7
Devices cleared under the same product code (JRY) and FDA review panel - the closest regulatory comparables to K900974.
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
K042118 · Zeus Scientific, Inc. · Apr 2005
BION EBV-G (VCA) TEST SYSTEM
K891785 · Bion Ent., Ltd. · Aug 1989
EBV EARLY ANTIGEN (R+D)
K884829 · Hillcrest Biologicals · Apr 1989
EBV IGM TEST
K822734 · Gull Laboratories, Inc. · Dec 1982
EBV-M KIT
K822985 · Litton Bionetics · Dec 1982
EBV-VCA ANTIBODY ASSAY KIT
K821849 · Biotech Research Laboratories, Inc. · Aug 1982
K900974 · INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
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