510(k) · Cleared
ClearedQuantex C4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · DBI Complement C4, Antigen, Antiserum, Control
Cleared on Sep 26, 1996 as substantially equivalent to K920010 (Instrumentation Laboratory CO, 1992) after a 111-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Sep 26, 1996
- Review
- 111 days
- Class
- Class II
- Product code
- DBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920010 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920010 IL Test Complement 4Instrumentation Laboratory CO · 1992
- This deviceK962198 Quantex C4Instrumentation Laboratory CO · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920010 | IL Test Complement 4 | Instrumentation Laboratory CO | 1992 | — |
| 0 (this device) | K962198 | Quantex C4 | Instrumentation Laboratory CO | 1996 | — |
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 DBI? 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 |
|---|---|---|---|
| * | K920010 | IL Test Complement 4Summary page 1…mL Buffer P/N 3000-22130 Classification name(s): 866.5240 Complement components immunological test systems Class II Identification of predicate device(s): IL Test™ C4 #K920010/B Description of the device/intended use(s): This product permits the quantitative in vitro diagnostic determination of Complem… | 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?
- Its one ancestor has no recall.
How does its category compare?
All DBI devicesDBI Complement C4, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DBI
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DBI
Too few DBI 510(k)s in any year since 2007 to give a median.
Recalls per year · DBI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DBI
1in 2024
MAUDE reports naming product code DBI, 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 | 1 | — | 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 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This product permits the quantitative in vitro diagnostic determination of Complement 4 in serum and plasma on the [Lab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4.
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/K962198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962198: Quantex C4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962198
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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