510(k) · Cleared
ClearedAutostat II Anti-PR 3 (C-Anca)Elisa, HY*Tec Anti-PR 3 (C-Anca)Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cogent Diagnotics, Ltd. · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Cleared on Apr 28, 1999 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 28, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- MOB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
Indications for Use - Autostat™TI] Kit. Enzyme linked immunosorbent assay method for the semi—quanfitafivc determination of specific IgG autoantibodies to Pr 3 in human serum. Uses: The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener’s granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA). For in vilro diagnostic use only. Indications…
Read the full statement (141 words)
Indications for Use - Autostat™TI] Kit.
Enzyme linked immunosorbent assay method for the semi—quanfitafivc determination of specific IgG autoantibodies to Pr 3 in human serum.
Uses:
The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of autoimmune vasculiticles including Wegener’s granulomatosis and other conditions associated with elevated anti-neutrophil cytoplasmic antibodies (c-ANCA).
For in vilro diagnostic use only.
Indications for Use - HyeTec Kit.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific 1¢G autoantibodies to Pr 3 in buman serum. This device is designed for use with the Hycor Hy*Tec Automated EIA instrument.
Uses:
The results of the anti-Pr 3 assay can be used as an aid in the diagnosis of auto-irumune vasculitides including Wegener’s granulomatosis and other conditions associated with elevated znti-neutrophil cytoplasmic antibodies (c-ANCA).
For in virro diagnostic use only.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990796: Autostat II Anti-PR 3 (C-Anca)Elisa, HY*Tec Anti-PR 3 (C-Anca)Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990796
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026