# K081249: Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jul 21, 2008 after 80 days
- Product code: DEB (Alpha-2-Macroglobulin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5620
- 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 K002852 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053073: N Antisera to Human ALPHA2-Macroglobulin, Dade Behring, Inc. (2006) Summary page 1.
- K012470: Modification to N Protein Standard SL, Dade Behring, Inc. (2001)
- K012468: Modification to N/T Protein Control SL, Dade Behring, Inc. (2001) Summary page 1.

## Indications for use
The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a 2 -macroglobulin in human serum and plasma on the Dimension Vista® System. Measurements of a 2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders. PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for; a¢-Acid Glycoprotein (A1AG) Immunoglobulin E (IGE) as-Antitrypsin (A1AT) Immunoglobulin G (1IGG, 1IGG-C*) a;-Macroglobulin (AZMAC) Immunoglobulin G Subclass 1 (IGG1) B2-Microglobulin (B2MIC) Immunoglobulin G Subclass 2 (IGG2) C3 Complement (C3) immunoglobulin G Subclass 3 (IGG3) C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4) Ceruloplasmin (CER) Immunoglobulin M (IGM) Haptoglobin (HAPT) Prealbumin (PREALB) Hemopexin (HPX) Retinol binding Protein (RBP) Homocysteine (HCYS) soluble Transferrin Receptor (STFR) Immunoglobulin A (1IGA) Transferrin {TRF) * For cerebrospinal fluid (CSF) PROTI CON L is an assayed, low-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vistae System in the quantitative determination of: al-Acid Glycoprotein (AIIAG) Immunoglobulin G (IGG) alI-Antitrypsin (AlAT) Immunoglobulin G Subclass 1 (IGGI) a2-Macroglobulin (A2MAC) Immunoglobulin G Subclass 2 (IGG2) C3 Complement (C3) Immunoglobulin G Subclass 3 (IGG3) C4 Complement (C4) Immunoglobulin G Subclass 4 (IGG4) Ceruloplasmin (CER) Immunoglobulin M (IGM) Haptoglobin (HAPT) Prealbumnin (PREALB) Hemopexin (HPX) Retinol binding Protein (RBP) Homocysteine (HCYS) soluble Transferrin Receptor (STFR) Irimmunoglobulin A (]GA) -specialty Albumin (sALB*) Immunoglobulin E (IGE) Transferrin (TRF) * For serum and plasma PROTi CON M is an assayed, mid-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a,-Acid Glycoprotein (AlAG) Immunoglobulin G (IGG) a1-Antitrypsin (AlAT) Immunoglobulin G Subclass 1 (IGGII) a2-Macroglobulin (A2MAC) Immunoglobulin G Subclass 2 (IGG2) P2-Microglobulin (1B2MIC) Immunoglobulin G Subclass 3 (IGG3) C3 Complement (C3) Immunoglobulin G Subclass 4 (IGG4) C4 Complement (C4) Immunoglobulin M (IGM) Ceruloplasmin (CER) Prealbumnin (PREALB) Haptoglobin (HAPT) Retinol binding Protein (RB3P) Hemopexin (HPX) soluble Transferrin Receptor (STFR) Homocysteine (HCYS) specialty Albumin (sALB*) Immunoglobulin A (IGA) Transferrin (TRF) Immunoglobulin E (IGE) * For serum and plasma PROT1 CON H is an assayed, high-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vlsta System in the quantitative determination of: as-Acid Glycoprotein (A1AG) Immunoglobulin G (IGG) a,-Antitrypsin (A1AT) Immunoglobulin G Subclass 1 (IGG1) ax-Macroglobulin (A2MAC) Immunoglobulin G Subclass 2 (IGG2) B,-Microglobulin (B2MIC) Immunoglobulin G Subclass 3 (IGG3) C3 Complement (C3) immunoglobulin G Subclass 4 (IGG4) C4 Complement (C4) Immunogiobulin M (IGM) Ceruloplasmin (CER) Prealbumin (PREALB) Haptoglobin (HAPT) Retinol binding Protein (RBP) Hemopexin (HPX) soluble Transferrin Receptor (STFR) Homocysteine (HCYS) specialty Atbumin (sALB*) Immunogilobulin A (IGA) Transferrin (TRF) immunoglobulin E (IGE) * For serum and plasma

Source page: https://510kreport.com/device/K081249
Methodology: https://510kreport.com/methodology