Cleared Traditional

K973822 - VIRGO ANCA SCREEN KIT

K973822 is an FDA 510(k) clearance for VIRGO ANCA SCREEN KIT, manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K973822 · Hemagen Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
37d
Days
Class 2
Risk

K973822 is an FDA 510(k) clearance for the VIRGO ANCA SCREEN KIT. Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology 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.

View all Hemagen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K973822

510(k) Number K973822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1997
Decision Date November 13, 1997
Days to Decision 37 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 105d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 Immunology devices follow this clearance model.

Regulatory Peers - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 64
Devices cleared under the same product code (MOB) and FDA review panel - the closest regulatory comparables to K973822.
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
K974702 · American Laboratory Products Co., Ltd. · Feb 1998
IMMUNO CONCEPTS ANCA TEST SYSTEM
K974463 · Immuno Concepts, Inc. · Feb 1998
IMMUNO CONCEPTS ANCA TEST SYSTEMS
K974478 · Immuno Concepts, Inc. · Feb 1998
PR 3 ANTIBODY KIT
K973823 · Hemagen Diagnostics, Inc. · Nov 1997
VIRGO PANCO KIT
K973824 · Hemagen Diagnostics, Inc. · Nov 1997
IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT
K971689 · Euro-Diagnostica AB · Oct 1997