510(k) · Cleared
ClearedST Aia-Pack Intact PTH Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Jun 21, 2007 as substantially equivalent to K992680 (Roche Diagnostics Corp., 1999) after a 199-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Jun 21, 2007
- Review
- 199 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954418 (1995). No later device cites it as a predicate yet.
- Root · 2 generations backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
- 1 generation backK992680 Elecsys Parathyroid Hormone Test SystemRoche Diagnostics Corp. · 1999 · Recalled
- This deviceK063605 ST Aia-Pack Intact PTH AssayTosoh Bioscience, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954418 | Intact Parathyroid Hormone (PTH) Immunoassay (Modification) | Nichols Institute Diagnostics | 1995 | — |
| −1 | K992680 | Elecsys Parathyroid Hormone Test System | Roche Diagnostics Corp. | 1999 | 1 |
| 0 (this device) | K063605 | ST Aia-Pack Intact PTH Assay | Tosoh Bioscience, Inc. | 2007 | — |
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 |
|---|---|---|---|
| * | K992680 | Elecsys Parathyroid Hormone Test SystemSummary page 1…ame: Parathyroid Hormone Test System Predicate Device: Roche Diagnostics Corp., Elecsys Parahyroid Hormone Test System K992680 Intended Use: The Tosoh Bioscience, Inc. ST AIA-PACK Intact PTH is designed fo… | 1999 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 4 other devices also cite its predicate K992680.
How does its category compare?
All CEW devicesCEW Radioimmunoassay, Parathyroid Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of the levels of parathyroid hormone in human serum and EDTA plasma on specific TOSOH AIA System analyzers. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium…
Read the full statement (121 words)
ST AIA-PACK Intact PTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of the levels of parathyroid hormone in human serum and EDTA plasma on specific TOSOH AIA System analyzers. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
The ST AIA-PACK Intact PTH CALIBRTOR SET is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK Intact PTH.
The AIA-PACK Intact PTH CONTROL SET is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Intact PTH Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063605: ST Aia-Pack Intact PTH Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063605
Report an extraction error
Are you the manufacturer?
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