510(k) · Cleared
Recalled · Class II · 2018IGG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DEW Igg, Antigen, Antiserum, Control
Cleared on Nov 4, 1998 as substantially equivalent to K862764 (Boehringer Mannheim Corp., 1986) after a 51-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- Nov 4, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- DEW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862764 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK862764 Tina-Quant (R) IggBoehringer Mannheim Corp. · 1986
- This deviceK983221 IGGAbbott Laboratories · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862764 | Tina-Quant (R) Igg | Boehringer Mannheim Corp. | 1986 | — |
| 0 (this device) | K983221 | IGG | Abbott Laboratories | 1998 | — |
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 DEW? 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 |
|---|---|---|---|
| * | K862764 | Tina-Quant (R) IggSummary page 1…of immunoglobulin G in the sample. Substantial Equivalence: The Immunoglobulin G assay is substantially equivalent to the Boehringer Mannheim® Immunoglobulin G assay (K862764) on the Hitachi® 717 Analyzer. Immunoglobulin G 510(k) Section 1l September 11, 1998 Page | 1gG S _Vilwp 050011… | 1986 |
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-1989-2019 | 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 DEW devicesDEW Igg, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DEW
FDA has decided no DEW device since 2007.
Median 510(k) review, days · DEW
Too few DEW 510(k)s in any year since 2007 to give a median.
Recalls per year · DEW
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DEW
4in 2024
MAUDE reports naming product code DEW, 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 | 4 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 1 | 4 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Immunoglobulin G assay is used for the quantitation of immunoglobulin G in human serum or plasma. Measurement of immunoglobulin G aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.
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/K983221 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983221: IGG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983221
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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