510(k) · Cleared
ClearedRoche Unimate HDL Direct Reagen (with Pol Claim)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · LBR Ldl & Vldl Precipitation, Hdl
Cleared on Nov 21, 1997 as substantially equivalent to K971902 (Roche Diagnostic Systems, Inc., 1997) after a 74-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Nov 21, 1997
- Review
- 74 days
- Class
- Class I
- Product code
- LBR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971902 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971902 Roche Unimate HDL Direct Reagent, Roche Calibrator HDL DirectRoche Diagnostic Systems, Inc. · 1997
- This deviceK973369 Roche Unimate HDL Direct Reagen (with Pol Claim)Roche Diagnostic Systems, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971902 | Roche Unimate HDL Direct Reagent, Roche Calibrator HDL Direct | Roche Diagnostic Systems, Inc. | 1997 | — |
| 0 (this device) | K973369 | Roche Unimate HDL Direct Reagen (with Pol Claim) | Roche Diagnostic Systems, Inc. | 1997 | — |
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 LBR? 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 |
|---|---|---|---|
| * | K971902 | Roche Unimate HDL Direct Reagent, Roche Calibrator HDL DirectSummary page 2…c Systems, Inc. claims equivalence. Table 2 Proprietary Name Predicate Product Name K number |Date of substantial equivalence Roche UNIMATE HDL Roche UNIMATE HDL Direct K971902 |6/16/97 Direct reagent reagent with POL claim) Description of the Device/Statement of Intended Use: The Roche UNIMATE HDL Di… | 1997 |
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 LBR devicesLBR Ldl & Vldl Precipitation, Hdl: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LBR
Too few LBR 510(k)s in any year since 2007 to give a median.
Recalls per year · LBR
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBR
8in 2025
MAUDE reports naming product code LBR, 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 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 4 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic device intended for use in clinical and physician’s office laboratories (POL) on COBAS MIRA systems for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum.
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/K973369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973369: Roche Unimate HDL Direct Reagen (with Pol Claim).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973369
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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