510(k) · Cleared
Recalled · Class II · 2018APOB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Cleared on Jan 26, 1999 as substantially equivalent to K964296 (Crestat Diagnostics, Inc., 1997) after a 130-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Jan 26, 1999
- Review
- 130 days
- Class
- Class II
- Product code
- DFC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964296 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964296 N-Assay Tia Apo B Test KitCrestat Diagnostics, Inc. · 1997
- This deviceK983281 APOBAbbott Laboratories · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964296 | N-Assay Tia Apo B Test Kit | Crestat Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K983281 | APOB | Abbott Laboratories | 1999 | — |
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 DFC? 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 DFC device
- #1 K253069 Lipoprotein (a) Molarity Assayscore 11.5 · 1 generation · 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 |
|---|---|---|---|
| * | K964296 | N-Assay Tia Apo B Test KitSummary page 2…I September 17, 1998 Page 1 ApoB_Vl1lwp 0000011 Substantial Equivalence: The Apolipoprotein B assay is substantially equivalent to the K-ASSAY® Apo B (K964296/8022) on the Hitachi® 717 Analyzer. Both assays yield similar Performance Characteristics. Similarities: » Both assays are in v… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2018 | Class II | Z-1994-2019 | Under Investigation by firm | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
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 DFC devicesDFC Lipoprotein, Low-Density, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DFC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFC
Too few DFC 510(k)s in any year since 2007 to give a median.
Recalls per year · DFC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFC
7in 2025
MAUDE reports naming product code DFC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 2 | 16 |
| 2025 | 1 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Apolipoprotein B assay is used for the quantitation of apolipoprotein B in human serum or plasma. Apolipoprotein B meaurements are useful in the diagnosis of premature coronary artery disease, hyper-b-lipoproteinemia, and hypo-b-lipoproteinemia.
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/K983281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983281: APOB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983281
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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