# K083445: N Antisera to Human Immunoglobulins (Igg, Iga and Igm) and N/T Protein Control LC

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Mar 24, 2009 after 123 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002852 (2000). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963974: Image-Immunochemistry System Urine Immunoglobulin, Beckman Instruments, Inc. (1997) Summary page 3.
- K042735: N Antisera to Human Immunoglobulins (Igg, Iga and Igm), Dade Behring, Inc. (2005) Summary page 3.
- K072435: Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control H, Dade Behring, Inc. (2007) Summary page 1.

## Most influential descendants
- K233663: N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (2023), 0 descendants of its own

## Recalls of this device
- Aug 30, 2022 · Class II · Z-0093-2023: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
- Aug 30, 2022 · Class II · Z-0094-2023: N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).

## Indications for use
In vitro diagnostic reagents for the quantitative determination of immunoglobulins (IgG, IgA and IgM) in human serum, heparinized and EDTA plasma, and IgG in human urine and cerebrospinal fluid (CSF) by means of immunonephelometry on the BNTM Systems. Measurement of immunoglobulins aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. N/T Protein Control LC is intended for use as an assayed intralaboratory quality control for assessment of precision and analytical bias in immunochemical determination of the proteins IgG in CSF, IgA in CSF, IgM in CSF, IgG in urine, transferrin in urine, albumin in urine and CSF, al-microglobulin in urine and total protein in urine and CSF, using the BNTM Systems.

Source page: https://510kreport.com/device/K083445
Methodology: https://510kreport.com/methodology