510(k) · Cleared
ClearedCobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL Direct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · MRR System, Test, Low Density, Lipoprotein
Cleared on Oct 1, 1998 as substantially equivalent to K924674 (Genzyme Corp., 1993) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 1, 1998
- Review
- 50 days
- Class
- Class I
- Product code
- MRR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922043 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922043 Roche Calibrator SerumRoche Diagnostic Systems, Inc. · 1992
- This deviceK982848 Cobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL DirectRoche Diagnostic Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922043 | Roche Calibrator Serum | Roche Diagnostic Systems, Inc. | 1992 | — |
| 0 (this device) | K982848 | Cobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL Direct | Roche Diagnostic Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 MRR? 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 MRR device
- #1 K241800 Atellica® CH HDL Cholesterol (HDLC)& Atellica®…score 8.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K924674 | Direct LDL Choles Immunoseparation ReagentSummary page 2…s, Inc. claims equivalence. Table 2 Product Name Predicate Product Date Predicate Name Predicate 510(k) Cleared Number COBAS INTEGRA Roche Reagent for LDL Direct 1/6/93 K924674 LDL Direct (LDL-D) Roche Calibrator LDL Direct Roche Calibrator Serum 6/16/92 K922043 019 Roche Diagnostic Syste… | 1993 |
| * | K922043 | Roche Calibrator SerumSummary page 2…e Predicate 510(k) Cleared Number COBAS INTEGRA Roche Reagent for LDL Direct 1/6/93 K924674 LDL Direct (LDL-D) Roche Calibrator LDL Direct Roche Calibrator Serum 6/16/92 K922043 019 Roche Diagnostic Systems. Inc. COBAS® INTEGRA LDL Direct Reagent Cassette Somerville, New Jersey 08876 510(k… | 1992 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MRR devicesMRR System, Test, Low Density, Lipoprotein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRR
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MRR
Too few MRR 510(k)s in any year since 2007 to give a median.
Recalls per year · MRR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRR
1in 2024
MAUDE reports naming product code MRR, 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 | 1 | — | 2 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The cassette COBAS INTEGRA LDL Direct (LDL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative determination of LDL-cholesterol direct concentration in serum and plasma. Low density lipoprotein cholesterol measurement, in conjunction with other lipid determinations, has been shown to be useful in assessing the risk of coronary heart disease. The Roche Calibrator LDL Direct is intended for use as…
Read the full statement (125 words)
The cassette COBAS INTEGRA LDL Direct (LDL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative determination of LDL-cholesterol direct concentration in serum and plasma. Low density lipoprotein cholesterol measurement, in conjunction with other lipid determinations, has been shown to be useful in assessing the risk of coronary heart disease.
The Roche Calibrator LDL Direct is intended for use as calibrator in quantitative Low Density Lipoprotein cholesterol assays. It is recommended for use with LDL Direct reagents on COBAS® chemistry systems. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
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/K982848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982848: Cobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL Direct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982848
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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