510(k) · Cleared
ClearedOptilite Low Level Albumin Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site Group, Ltd. · DCF Albumin, Antigen, Antiserum, Control
Cleared on Aug 25, 2016 as substantially equivalent to K972929 (Behring Diagnostics, Inc., 1997) and 2 other predicates after a 255-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Aug 25, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- DCF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K895883 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895883 | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | 1989 | — |
| −1 | K972929 | N Antiserum to Human Albumin | Behring Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K153560 | Optilite Low Level Albumin Kit | The Binding Site Group, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 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 DCF? 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? (3)
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 |
|---|---|---|---|
| * | K972929 | N Antiserum to Human AlbuminSummary page 5…rol does not have an assigned value. J. Substantial equivalence information: 1. Predicate device name(s) and 510(k) number(s): N Antiserum to Human Albumin K972929 N Protein Standard SL K964062 NT Protein Control SL K964065… | 1997 |
| * | K964062 | N Protein Strandard SLSummary page 5…J. Substantial equivalence information: 1. Predicate device name(s) and 510(k) number(s): N Antiserum to Human Albumin K972929 N Protein Standard SL K964062 NT Protein Control SL K964065 Optili… | 1996 |
| * | K964065 | N/T Protein Control SLSummary page 5…on: 1. Predicate device name(s) and 510(k) number(s): N Antiserum to Human Albumin K972929 N Protein Standard SL K964062 NT Protein Control SL K964065 Optilite Low Level Albumin Kit… | 1996 |
| † | K121045 | Human Albumin CSF Kit | 2013 |
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 27 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K972929.
How does its category compare?
All DCF devicesDCF Albumin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DCF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DCF
167in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DCF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DCF
12in 2025
MAUDE reports naming product code DCF, 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 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 167 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 1 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Optilite Low Level Albumin Kit is intended for the quantitative in vitro measurement of albumin in CSF, urine and serum using the Binding Site Optilite analyser to aid in the diagnosis of kidney and intestinal diseases. This test should be used in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153560: Optilite Low Level Albumin Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153560
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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