510(k) · Cleared
ClearedDimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
Cleared on Jul 21, 2008 as substantially equivalent to K053073 (Dade Behring, Inc., 2006) and 2 other predicates after an 80-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 21, 2008
- Review
- 80 days
- Class
- Class II
- Product code
- DEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002852 (2000). 6 ancestors in all, the oldest K860894 (1986). 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 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −1 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K081249 | Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System… | Dade Behring, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 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 DEB? 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 |
|---|---|---|---|
| * | K053073 | N Antisera to Human ALPHA2-MacroglobulinSummary page 1…nel: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: Dade Behring N Antisera to Human a 2 - macroglobulin - K053073 N Protein Standard SL - KO 12470 N/T Protein Controls SL - K012468… | 2006 |
| * | K012470 | Modification to N Protein Standard SL | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 1…Antisera to Human a 2 - macroglobulin - K053073 N Protein Standard SL - KO 12470 N/T Protein Controls SL - K012468 4. Device Descriptions: Dimension Vista® A2MAC Flex® reagent cartridge Proteins contained in human body fluids form immune comple… | 2001 |
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 8 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All DEB devicesDEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DEB
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DEB
Too few DEB 510(k)s in any year since 2007 to give a median.
Recalls per year · DEB
No recall names DEB since 2007.
Adverse event reports per year · DEB
No MAUDE report names DEB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (440 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081249 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081249: Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension Vista Sysyem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081249
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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