510(k) · Cleared
ClearedAxsym Intact PTH, Model 2G06
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Systems Laboratories, Inc. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on May 31, 2002 as substantially equivalent to K896294 (Diagnostic Systems Laboratories, Inc., 1989) after a 67-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- May 31, 2002
- Review
- 67 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896294 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK896294 DSL I-PTH (DSL #8000)Diagnostic Systems Laboratories, Inc. · 1989 · Recalled
- This deviceK020945 Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896294 | DSL I-PTH (DSL #8000) | Diagnostic Systems Laboratories, Inc. | 1989 | 1 |
| 0 (this device) | K020945 | Axsym Intact PTH, Model 2G06 | Diagnostic Systems Laboratories, Inc. | 2002 | — |
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 CEW? 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 CEW device
- #1 K231927 Elecsys PTH , Elecsys PTH STATscore 7.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K896294 | DSL I-PTH (DSL #8000)Summary page 3…41 The AxSYM® Intact PTH assay is substantially eqfiivalent to another device marketed in the United States. We claim equivalence to the DSL-8000 ACTIVE™ Intact PTH IRMA (K896294). 442 To demonstrate substantial equivalence between the two assays, serum and plasma samples were assayed using both methods. M… | 1989 |
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 a recall.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEW
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEW
160in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEW
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEW
37in 2025
MAUDE reports naming product code CEW, 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 | 4 | 160 | 1 | 0 |
| 2008 | 0 | — | 1 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 3 | 23 |
| 2011 | 0 | — | 0 | 97 |
| 2012 | 1 | — | 0 | 124 |
| 2013 | 2 | — | 1 | 172 |
| 2014 | 1 | — | 0 | 167 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 0 | — | 2 | 98 |
| 2017 | 2 | — | 0 | 83 |
| 2018 | 0 | — | 0 | 65 |
| 2019 | 1 | — | 0 | 77 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 2 | 188 |
| 2023 | 1 | — | 0 | 82 |
| 2024 | 2 | — | 2 | 67 |
| 2025 | 0 | — | 1 | 37 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AxSYM® Intact PTH is a Microparticle Enzyme Immunoassay (MEIA) for the in vitro quantitative determination of intact human parathyroid hormone (I PTH) in human serum or plasma on the AxSYM® system. The AxSYM® I PTH assay is intended for use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.
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/K020945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020945: Axsym Intact PTH, Model 2G06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020945
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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