# K153560: Optilite Low Level Albumin Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site Group, Ltd.
- Decided: Aug 25, 2016 after 255 days
- Product code: DCF (Albumin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895883 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972929: N Antiserum to Human Albumin, Behring Diagnostics, Inc. (1997) Summary page 5.
- K964062: N Protein Strandard SL, Behring Diagnostics, Inc. (1996) Summary page 5.
- K964065: N/T Protein Control SL, Behring Diagnostics, Inc. (1996) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K153560
Methodology: https://510kreport.com/methodology