510(k) · Cleared
ClearedOptilite IgA CSF Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Jan 23, 2019 as substantially equivalent to K993549 (Beckman Coulter, Inc., 2000) after a 70-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Jan 23, 2019
- Review
- 70 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771603 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
- 2 generations backK963868 Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M…Beckman Instruments, Inc. · 1997 · Recalled
- 1 generation backK993549 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000
- This deviceK183151 Optilite IgA CSF KitThe Binding Site Group, Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771603 | Immochemistry System | Beckman Instruments, Inc. | 1977 | — |
| −2 | K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) | Beckman Instruments, Inc. | 1997 | 2 |
| −1 | K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K183151 | Optilite IgA CSF Kit | The Binding Site Group, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 CFN? 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 CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Summary page 5…device name(s) and 510(k) number(s): Beckman Coulter Low Concentration Immunoglobulin A (IGALC) reagent and Cerebrospinal Fluid Protein Calibrator (CSF CAL) (K993549) Optilite IgA CSF Kit… | 2000 |
| † | K110035 | Indiko | 2011 |
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?
- The line of descent spans 42 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K993549.
How does its category compare?
All CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, 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 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.
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/K183151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K183151: Optilite IgA CSF Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K183151
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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