# K972929: N Antiserum to Human Albumin

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Oct 20, 1997 after 73 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: 1 generation back to K895883 (1989). 1 ancestor in all.
5 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895883: Beckman MA Microalbumin Reagent Kit, Beckman Instruments, Inc. (1989) Summary page 1.

## Most influential descendants
- K101203: Tina-Quant Albumin Gen 2 (2010), 1 descendant of its own
- K153560: Optilite Low Level Albumin Kit (2016), 0 descendants of its own
- K113072: Tina-Quant Albumin Gen.2 (2012), 0 descendants of its own
- K042643: Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I and II (2004), 0 descendants of its own
- K033525: Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114, DC114 (2004), 0 descendants of its own

## Indications for use
N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.

Source page: https://510kreport.com/device/K972929
Methodology: https://510kreport.com/methodology