510(k) · Cleared
ClearedTina-Quant Ferritin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Cleared on Jul 30, 1997 as substantially equivalent to K860137 (Boehringer Mannheim Corp., 1986) after a 275-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.
- Decided
- Jul 30, 1997
- Review
- 275 days
- Class
- Class II
- Product code
- JMG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K860137 (1986). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K100538Tina-Quant Ferritin Gen. 4Roche Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860137 | Enzymun-Test Ferritin | Boehringer Mannheim Corp. | 1986 | — |
| 0 (this device) | K964282 | Tina-Quant Ferritin Assay | Boehringer Mannheim Corp. | 1997 | — |
| +1 | K100538 | Tina-Quant Ferritin Gen. 4 | Roche Diagnostics | 2010 | — |
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 JMG? 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 JMG device
- #1 K234052 Access Ferritinscore 7.3 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K860137 | Enzymun-Test FerritinSummary page 3…other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Enzymun- Test® Ferritin assay (K860137). Continued on next page page 26 ( BOEHRINGE® 10(k) Summary, Continued l MANNHEIM CORPORATION 4. Device Desc… | 1986 |
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 |
|---|---|---|---|
| K100538 | Tina-Quant Ferritin Gen. 4 | 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, K100538 (Roche Diagnostics, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JMG devicesJMG Radioimmunoassay (Two-Site Solid Phase), Ferritin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JMG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JMG
Too few JMG 510(k)s in any year since 2007 to give a median.
Recalls per year · JMG
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JMG
12in 2025
MAUDE reports naming product code JMG, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 12 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 0 | — | 1 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using clinical-chemistry analyzers. A variety of methods are available for determining ferritin, e.g. radio-immunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA), luminescence immunoassay (LIA) and nephelometric immunoassay. The assay is unaffected by icterus (bilirubin up to 60 mg/dl), hemolysis…
Read the full statement (101 words)
Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using clinical-chemistry analyzers.
A variety of methods are available for determining ferritin, e.g. radio-immunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), fluorescence immunoassay (FIA), luminescence immunoassay (LIA) and nephelometric immunoassay.
The assay is unaffected by icterus (bilirubin up to 60 mg/dl), hemolysis (Hb < 0.5 g/dl), lipemia (triglycerides < 1500 mg/dl) and rheumatoid factor (< 100 IU/ml).
(Criterion: recovery within ± 10% of initial value.)
For diagnostic purposes, the ferritin findings should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.
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/K964282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964282: Tina-Quant Ferritin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964282
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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