510(k) · Cleared
ClearedN Latex Ige Mono Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DGC Ige, Antigen, Antiserum, Control
Cleared on Jul 7, 1999 as substantially equivalent to K890530 (Behring Diagnostics, Inc., 1989) after a 43-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Jul 7, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- DGC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890530 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK890530 N Latex Ige Kit (Immunoglobulin E Reagents)Behring Diagnostics, Inc. · 1989
- This deviceK991787 N Latex Ige Mono ReagentDade Behring, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK063425 Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator…Dade Behring, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063425Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890530 | N Latex Ige Kit (Immunoglobulin E Reagents) | Behring Diagnostics, Inc. | 1989 | — |
| 0 (this device) | K991787 | N Latex Ige Mono Reagent | Dade Behring, Inc. | 1999 | — |
| +1 | K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1… | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 DGC? 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 DGC device
- #1 K231151 Kenota 1 Total IgE; Kenota 1 (instrument)score 8.0 · 3 generations · 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 |
|---|---|---|---|
| * | K890530 | N Latex Ige Kit (Immunoglobulin E Reagents)Summary page 1…mmunoglobulins A, G, M, D, and E immunological test system Classification Number: Class Il (866.5510) 3. Identification of the Legally Marketed Device: N Latex IgE kit (K890530) 4. Device Description: N Latex IgE mono Reagent is intended to be used together with the Behring Nephelometer Systems for the q… | 1989 |
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 |
|---|---|---|---|
| K063425 | Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control… | 2007 | 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?
- Its one ancestor has no recall.
- Of its descendants, K063425 (Dade Behring, Inc., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DGC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DGC
Too few DGC 510(k)s in any year since 2007 to give a median.
Recalls per year · DGC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DGC
2in 2021
MAUDE reports naming product code DGC, 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 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
In vitro diagnostic reagent for the quantitative determination of IgE in human serum or plasma by particle enhanced immunonephelometry using the Behring Nephelometer Systems, and 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/K991787 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991787: N Latex Ige Mono Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991787
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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