510(k) · Cleared
ClearedImmulite CK-MB, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Cleared on Jun 10, 1998 as substantially equivalent to K903025 (Roche Diagnostic Systems, Inc., 1990) after a 44-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jun 10, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- JHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903025 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK903025 Roche Isomune- CKRoche Diagnostic Systems, Inc. · 1990
- This deviceK981495 Immulite CK-MB, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests)Diagnostic Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903025 | Roche Isomune- CK | Roche Diagnostic Systems, Inc. | 1990 | — |
| 0 (this device) | K981495 | Immulite CK-MB, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests) | Diagnostic Products Corp. | 1998 | — |
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 JHS? 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 |
|---|---|---|---|
| * | K903025 | Roche Isomune- CKSummary page 1…s tests. Diagnostic Products Corporation (DPC) . 5700 West 96th Street Los Angeles, CA 90045-5597 DPC's establishment Registration No. is 2017183 Roche® Isomune® ~CK (K903025) IMMULITE® CK-MB is a two-site chemllummescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer. IMMULI… | 1990 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JHS devicesJHS Differential Rate Kinetic Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JHS
Too few JHS 510(k)s in any year since 2007 to give a median.
Recalls per year · JHS
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHS
10in 2025
MAUDE reports naming product code JHS, 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 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 26 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 5 | 6 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 13 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IMMULITE CK-MB is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) antigen in heparinized plasma or serum. It is intended strictly for i vitro use as an aid in patient management and the assessment of prognosis of myocardial infarction.
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/K981495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981495: Immulite CK-MB, Catalog # LKCP1 (100 Tests), LKCP5 (500 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981495
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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