510(k) · Cleared
ClearedIntegra Reagent Cassette for Apolipoprotein a-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Cleared on Apr 14, 1999 as substantially equivalent to K954992 (Roche Diagnostic Systems, Inc., 1996) after a 49-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Apr 14, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- DER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954992 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954992 Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1996
- This deviceK990594 Integra Reagent Cassette for Apolipoprotein a-1Roche Diagnostics Corp. · 1999
- Descendant · cites it directly · 0 of its ownK013278 Tina-Quant Apolipoprotein a-1 Ver.2Roche Diagnostics Corp. · 2001
Most influential descendants
Showing 1 of 1 · See all- K013278Tina-Quant Apolipoprotein a-1 Ver.2Roche Diagnostics Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954992 | Roche Cobas Integra Reagent Cassettes | Roche Diagnostic Systems, Inc. | 1996 | — |
| 0 (this device) | K990594 | Integra Reagent Cassette for Apolipoprotein a-1 | Roche Diagnostics Corp. | 1999 | — |
| +1 | K013278 | Tina-Quant Apolipoprotein a-1 Ver.2 | Roche Diagnostics Corp. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 DER? 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 |
|---|---|---|---|
| * | K954992 | Roche Cobas Integra Reagent CassettesSummary page 2…cial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche INTEGRA Reagent Cassette for Apolipoprotein A-1 (K954992) The following table illustrates the similarities between modified INTEGRA Apolipoprotein A-1 and the predicate device. Specific… | 1996 |
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 |
|---|---|---|---|
| K013278 | Tina-Quant Apolipoprotein a-1 Ver.2 | 2001 | 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?
How does its category compare?
All DER devicesDER Alpha-1-Lipoprotein, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DER
FDA has decided no DER device since 2007.
Median 510(k) review, days · DER
Too few DER 510(k)s in any year since 2007 to give a median.
Recalls per year · DER
No recall names DER since 2007.
Adverse event reports per year · DER
2in 2024
MAUDE reports naming product code DER, 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 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For the quantitative determination of apolipoprotein A-1 in serum and plasma.
A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders and atherosclerosis,
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/K990594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990594: Integra Reagent Cassette for Apolipoprotein a-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990594
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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