510(k) · Cleared
ClearedVirgo Anca Screen Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Nov 13, 1997 as substantially equivalent to K954105 (Scimedx Corp., 1996) and 1 other predicate after a 37-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Nov 13, 1997
- Review
- 37 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954105 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954105 Eia Kit for the Detction of Anti-PR3 AntibodiesScimedx Corp. · 1996
- This deviceK973822 Virgo Anca Screen KitHemagen Diagnostics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954105 | Eia Kit for the Detction of Anti-PR3 Antibodies | Scimedx Corp. | 1996 | — |
| 0 (this device) | K973822 | Virgo Anca Screen Kit | Hemagen Diagnostics, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MOB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MOB device
- #1 K261466 Alegria Flash MPO; Alegria Flash PR3; Alegria…score 11.9 · 1 generation · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954105 | Eia Kit for the Detction of Anti-PR3 AntibodiesSummary page 1…assification Name: Antineutrophil Cytoplasmic Antibodies test system Predicate Devices a. Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies {510 (k) Docket No. K 954105} b. Scimedx EIA Kit For the Detection of Anti-MPO Antibodies {510 (k) Docket No. K 954062} 510 (k) Summary Page 1 === Page 2… | 1996 |
| * | K954062 | Eia Kit for the Detection of Anti-Mpo AntibodiesSummary page 1…Scimedx EIA Kit For the Detection of Anti-PR3 Antibodies {510 (k) Docket No. K 954105} b. Scimedx EIA Kit For the Detection of Anti-MPO Antibodies {510 (k) Docket No. K 954062} 510 (k) Summary Page 1 3. Description of Device An enzyme-linked immunosorbent assay (ELISA) designed for the… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K954105.
How does its category compare?
All MOB devicesMOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOB
221in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOB
1in 2012
MAUDE reports naming product code MOB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 379 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 221 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection of autoantibodies to the antigens Proteinase 3 (PR-3) and myeloperoxidase (MPO) in human serum. The presence of these antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Wegener's granulomatosis (WG), polyarteritis, necrotizing glomerulonephritis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (ANCA). Since a positive test result with this assay does not indicate which ANCA is (are) present, all positives should be confirmed using assays designed for particular ANCA specificities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973822: Virgo Anca Screen Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973822
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026