510(k) · Cleared
ClearedNichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · CEW Radioimmunoassay, Parathyroid Hormone
Cleared on Jan 26, 2004 as substantially equivalent to K013992 (Nichols Institute Diagnostics, 2001) after a 104-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jan 26, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- CEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013992 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK013992 Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone…Nichols Institute Diagnostics · 2001
- This deviceK033302 Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040Nichols Institute Diagnostics · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013992 | Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84)… | Nichols Institute Diagnostics | 2001 | — |
| 0 (this device) | K033302 | Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040 | Nichols Institute Diagnostics | 2004 | — |
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 7.7 · 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 |
|---|---|---|---|
| * | K013992 | Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) ImmunoassaySummary page 1…Regulation Number: 862.1545 Product Code: CEW, Clinical Chemistry 4. Predicate Device: Nichols Advantage Bio-Intact PTH (1-84) K01 3992 5. Device Description: The Nichols Advantage Aldosterone assay contains sufficient reagents for 100 tests. The assay is a dire… | 2001 |
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.
- 1 other device also cites its predicate K013992.
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?
The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA plasma. 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. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033302 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033302: Nichols Advantage Bio-Intact PTH (1-84) Assay, Model 62-7040.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033302
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