510(k) · Cleared
Recalled · Class II · 2017Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JZG System, Test, Beta-2-Microglobulin Immunological
Cleared on Mar 13, 2009 as substantially equivalent to K002731 (Dade Behring, Inc., 2000) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 1999. It has been recalled 4 times.
- Decided
- Mar 13, 2009
- Review
- 109 days
- Class
- Class II
- Product code
- JZG
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 2 generations to K992858 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK992858 Abbott Axsym HomocysteineAbbott Laboratories · 1999 · Recalled
- 1 generation backK052788 N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HDade Behring, Inc. · 2006 · Recalled
- This deviceK083463 Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992858 | Abbott Axsym Homocysteine | Abbott Laboratories | 1999 | 1 |
| −1 | K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H | Dade Behring, Inc. | 2006 | 2 |
| 0 (this device) | K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator… | Siemens Healthcare Diagnostics | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 JZG? 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? (2)
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 |
|---|---|---|---|
| * | K002731 | N Latex B2-MicroglobulinSummary page 1…Product Code: JZG, JIX, JJY Panel: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: 2 - microglobulin - K002731 Siemens N Latex 11 N Protein Standard SL - K052788 N/T Protein Controls SL - K052788 4. Device Descriptions: D… | 2000 |
| * | K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HSummary page 2…emistry (75) 3. Identification of the Legally Marketed Devices: 2 - microglobulin - K002731 Siemens N Latex 11 N Protein Standard SL - K052788 N/T Protein Controls SL - K052788 4. Device Descriptions: Dimension Vista® B2MIC Flex® reagent cartridge Proteins contained i… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2017 | Class II | Z-0174-2018 | Nonconforming Material/Component | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER). |
| May 23, 2017 | Class II | Z-0175-2018 | Nonconforming Material/Component | Complaint of high amount of ceruloplasmin patient results below the reference range (< 20 mg/dL [0.2 g/L]. PROT1 CAL and corresponding PROT1 CON L, M, and H are inaccurately assigned for ceruloplasmin (CER). |
| Nov 3, 2015 | Class II | Z-1030-2016 | Nonconforming Material/Component | Siemens Healthcare Diagnostics has confirmed an increase in the rate of Abnormal Assay errors and calibration failures with the Dimension Vista B2MIC Flex reagent cartridge: Dimension Vista System Flex reagent cartridge and urine… |
| Jul 23, 2015 | Class II | Z-2450-2015 | Environmental control | customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 2 other devices also cite its predicate K002731.
How does its category compare?
All JZG devicesJZG System, Test, Beta-2-Microglobulin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JZG
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JZG
Too few JZG 510(k)s in any year since 2007 to give a median.
Recalls per year · JZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JZG
1in 2024
MAUDE reports naming product code JZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 50 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The B2MIC method is an in vitro diagnostic test for the quantitative measurement of β2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista® System. Measurements of beta-2-microglobulin, aid in the diagnosis of active rheumatoid arthritis and kidney disease. PROT1 CON L is an assayed, low-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in…
Read the full statement (350 words)
The B2MIC method is an in vitro diagnostic test for the quantitative measurement of β2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista® System. Measurements of beta-2-microglobulin, aid in the diagnosis of active rheumatoid arthritis and kidney disease.
PROT1 CON L is an assayed, low-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:
a1-Acid Glycoprotein (A1AG)
a1-Antitrypsin (A1AT)
a2-Macroglobulin (A2MAC)
β2-Microglobulin (B2MIC, B2MU**)
C3 Complement (C3)
C4 Complement (C4)
Ceruloplasmin (CER)
Haptoglobin (HAPT)
Hemopexin (HPX)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG)
Immunoglobulin G Subclass 1 (IGG1)
Immunoglobulin G Subclass 2 (IGG2)
Immunoglobulin G Subclass 3 (IGG3)
Immunoglobulin G Subclass 4 (IGG4)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
Retinol binding Protein (RBP)
soluble Transferrin Receptor (STFR)
specialty Albumin (sALB*)
Transferrin (TRF)
* For serum and plasma
** For urine
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
a1-Acid Glycoprotein (A1AG)
a1-Antitrypsin (A1AT)
a2-Macroglobulin (A2MAC)
β2-Microglobulin (B2MIC, B2MU**)
C3 Complement (C3)
C4 Complement (C4)
Ceruloplasmin (CER)
Haptoglobin (HAPT)
Hemopexin (HPX)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG, IGG-C*, IGG-U**)
Immunoglobulin G Subclass 1 (IGG1)
Immunoglobulin G Subclass 2 (IGG2)
Immunoglobulin G Subclass 3 (IGG3)
Immunoglobulin G Subclass 4 (IGG4)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
Retinol binding Protein (RBP)
soluble Transferrin Receptor (STFR)
Transferrin (TRF)
*For cerebrospinal fluid (CSF)
**For Urine
PROT1 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:
a1-Acid Glycoprotein (A1AG)
a1-Antitrypsin (A1AT)
a2-Macroglobulin (A2MAC)
β2-Microglobulin (B2MIC, B2MU**)
C3 Complement (C3)
C4 Complement (C4)
Ceruloplasmin (CER)
Haptoglobin (HAPT)
Hemopexin (HPX)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG)
Immunoglobulin G Subclass 1 (IGG1)
Immunoglobulin G Subclass 2 (IGG2)
Immunoglobulin G Subclass 3 (IGG3)
Immunoglobulin G Subclass 4 (IGG4)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
Retinol binding Protein (RBP)
soluble Transferrin Receptor (STFR)
specialty Albumin (sALB*)
Transferrin (TRF)
* For serum and plasma
** For urine
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/K083463 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083463: Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension Vista Protein 1 Control M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083463
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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