510(k) · Cleared
Recalled · 2011Active Inhibin-a Elisa, Model DSL-10-28100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Systems Laboratories, Inc. · NDR Enzyme Immunoassay, Inhibin-A
Cleared on Dec 5, 2000 after a 144-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Dec 5, 2000
- Review
- 144 days
- Class
- Class I
- Product code
- NDR
- Recalls
- 4
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK002128 Active Inhibin-a Elisa, Model DSL-10-28100Diagnostic Systems Laboratories, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK070144 Inhibin a Calibrators & Controls on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070144Inhibin a Calibrators & Controls on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002128 | Active Inhibin-a Elisa, Model DSL-10-28100 | Diagnostic Systems Laboratories, Inc. | 2000 | — |
| +1 | K070144 | Inhibin a Calibrators & Controls on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDR? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070144 | Inhibin a Calibrators & Controls on the Access Immunoassay Systems | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 31, 2011 | Not classified | Z-2774-2011 | Process design | The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results… |
| Mar 31, 2011 | Not classified | Z-2772-2011 | Process design | The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results… |
| Mar 31, 2011 | Not classified | Z-2773-2011 | Process design | The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results… |
| Mar 31, 2011 | Not classified | Z-2775-2011 | Process design | The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070144 (Beckman Coulter, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NDR devicesNDR Enzyme Immunoassay, Inhibin-A: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDR
FDA has decided no NDR device since 2007.
Median 510(k) review, days · NDR
Too few NDR 510(k)s in any year since 2007 to give a median.
Recalls per year · NDR
3in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDR
1in 2022
MAUDE reports naming product code NDR, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 3 | 1 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K002128 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002128: Active Inhibin-a Elisa, Model DSL-10-28100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002128
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026