510(k) · Cleared
ClearedHemagen Anti Cardiolipin Screen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Jun 3, 1997 as substantially equivalent to K932373 (Hemagen Diagnostics, Inc., 1993) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 3, 1997
- Review
- 74 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932373 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932373 Hemagen Cardiolipin Antibody Kit (Eia METHOD0Hemagen Diagnostics, Inc. · 1993
- This deviceK971039 Hemagen Anti Cardiolipin ScreenHemagen Diagnostics, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932373 | Hemagen Cardiolipin Antibody Kit (Eia METHOD0 | Hemagen Diagnostics, Inc. | 1993 | — |
| 0 (this device) | K971039 | Hemagen Anti Cardiolipin Screen | Hemagen Diagnostics, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 MID? 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 MID device
- #1 K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagentscore 8.8 · 2 generations · 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 |
|---|---|---|---|
| * | K932373 | Hemagen Cardiolipin Antibody Kit (Eia METHOD0Summary page 1…al test system, multiple \ autoantibodies {21 CFR 866.5660} | 3 Predicate Device(s) a. Hemagen ® Anti-Cardiolipin IgG and igM {EIA method} Reference 510 (k) Docket No. K 932373 b. Hemagen ® Anti-Cardiolipin IgA Calibrator Reagents {EIA method} Reference 510 (k) Docket No. K 941840 510(k) Summary - Page… | 1993 |
| * | K941840 | Hemagen Acl Iga CalibratorSummary page 1…rdiolipin IgG and igM {EIA method} Reference 510 (k) Docket No. K 932373 b. Hemagen ® Anti-Cardiolipin IgA Calibrator Reagents {EIA method} Reference 510 (k) Docket No. K 941840 510(k) Summary - Page 1 | 2 Device Names """""!———-,lmw’ PAGE Description of Device The ELISA methodology is… | 1994 |
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.
- 3 other devices also cite its predicate K932373.
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MID
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MID
234in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MID
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MID
1in 2023
MAUDE reports naming product code MID, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 234 | 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 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The anti Cardiolipin Screen is indicated for the screening of patient serum for the presence of igG, IgM, and IgA autoantibodies to cardiolipin. Autoantibodies to aCl are typically observed in patients with systemic lupus erythematosus and other connective tissue diseases. This assay is intended to be utilized as an aid in the diagnosis of antiphospholipid syndrome.
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/K971039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971039: Hemagen Anti Cardiolipin Screen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971039
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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