510(k) · Cleared
ClearedAutostat II Anti-GPC Elisa, HY.Tec Anti-GPC Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cogent Diagnotics, Ltd. · MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Cleared on Aug 24, 1999 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 24, 1999
- Review
- 76 days
- Class
- Class II
- Product code
- MLE
- 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 MLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 MLE devicesMLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLE
FDA has decided no MLE device since 2007.
Median 510(k) review, days · MLE
Too few MLE 510(k)s in any year since 2007 to give a median.
Recalls per year · MLE
No recall names MLE since 2007.
Adverse event reports per year · MLE
No MAUDE report names MLE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum. The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. For in vitro diagnostic use only. Enzyme…
Read the full statement (142 words)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum.
The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
For in vitro diagnostic use only.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GPC in human serum. This device is designed for use with the Hycor HyeTec Automated EIA instrument.
The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
For in vitro 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/K991942 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991942: Autostat II Anti-GPC Elisa, HY.Tec Anti-GPC Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991942
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026