510(k) · Cleared
ClearedAcs LH2 Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Corning Diagnostics Corp. · CEP Radioimmunoassay, Luteinizing Hormone
Cleared on Jun 21, 1996 as substantially equivalent to K910198 (Ciba Corning Diagnostics Corp., 1991) after a 24-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Jun 21, 1996
- Review
- 24 days
- Class
- Class I
- Product code
- CEP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910198 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK910198 Ciba Corning Acs LH ImmunoassayCiba Corning Diagnostics Corp. · 1991
- This deviceK962041 Acs LH2 ImmunoassayCiba Corning Diagnostics Corp. · 1996
- Descendant · cites it directly · 0 of its ownK101460 Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K101460Loci 8 Calibrator, Model KC 646Siemens Healthcare Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910198 | Ciba Corning Acs LH Immunoassay | Ciba Corning Diagnostics Corp. | 1991 | — |
| 0 (this device) | K962041 | Acs LH2 Immunoassay | Ciba Corning Diagnostics Corp. | 1996 | — |
| +1 | K101460 | Loci 8 Calibrator, Model KC 646 | Siemens Healthcare Diagnostics | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 CEP? 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? (1)
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 |
|---|---|---|---|
| * | K910198 | Ciba Corning Acs LH ImmunoassaySummary page 1…CI%Luteinizing hormone test system, 21 CFR 862.1485 Predicate Device Information Name: ACS LH Immunoassay Manufacturer: Ciba Corning Diagnostics Corp. §10(k) Number: K910198 Device Description The Ciba Coming ASC LH2 assay is a two-site chemilumometric (sandwhich) assay which uses constant amounts of… | 1991 |
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 |
|---|---|---|---|
| K101460 | Loci 8 Calibrator, Model KC 646 | 2010 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K101460 (Siemens Healthcare Diagnostics, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CEP devicesCEP Radioimmunoassay, Luteinizing Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEP
FDA has decided no CEP device since 2007.
Median 510(k) review, days · CEP
Too few CEP 510(k)s in any year since 2007 to give a median.
Recalls per year · CEP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEP
1in 2023
MAUDE reports naming product code CEP, 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 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of ACS LH2 is for the quantitative determination of LH in serum using the Ciba Corning Automated Chemiluminescence Systems.
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/K962041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962041: Acs LH2 Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962041
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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