510(k) · Cleared
Recalled · Class II · 2017Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type Lambda, Dimension Vista Protein 1 Cal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · DFH Kappa, Antigen, Antiserum, Control
Cleared on Dec 19, 2008 as substantially equivalent to K860894 (Behring Diagnostics, Inc., 1986) and 2 other predicates after a 112-day review. Its family tree reaches back 2 generations to 2000. It has been recalled once.
- Decided
- Dec 19, 2008
- Review
- 112 days
- Class
- Class II
- Product code
- DFH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002852 (2000). 5 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) | K082503 | Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains… | Siemens Healthcare Diagnostics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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 DFH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DFH device
- #1 K253358 Diazyme Human Kappa (k) Free Light Chain…score 10.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K860894 | Behring Nephelometer SystemSummary page 2…anel: Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: Dade Behring N Antisera to Human Immunoglobulin/L-chains - K860894 N Protein Standard SL - K012470 N/T Protein Controls SL - K012468 4. D… | 1986 |
| * | K012470 | Modification to N Protein Standard SLSummary page 2…ication of the Legally Marketed Devices: Dade Behring N Antisera to Human Immunoglobulin/L-chains - K860894 N Protein Standard SL - K012470 N/T Protein Controls SL - K012468 4. Device Descriptions: Dimension Vista® KAPPA Flex® reagent car… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 2…N Antisera to Human Immunoglobulin/L-chains - K860894 N Protein Standard SL - K012470 N/T Protein Controls SL - K012468 4. Device Descriptions: Dimension Vista® KAPPA Flex® reagent cartridge Proteins contained in human body fluids form immune com… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2017 | Class II | Z-0173-2018 | 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). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 16 other devices also cite its predicate K860894.
How does its category compare?
All DFH devicesDFH Kappa, 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 · DFH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFH
340in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DFH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFH
10in 2025
MAUDE reports naming product code DFH, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 4 | 340 | 0 | 11 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Dimension Vista® KAPPA Flex® reagent cartridge: The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, kappa type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's…
Read the full statement (627 words)
Dimension Vista® KAPPA Flex® reagent cartridge:
The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, kappa type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.
Dimension Vista® PROT 1 CAL:
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for;
as-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA)
as-Antitrypsin (A1AT) Immunoglobulin E (IGE)
dp- Macroglobulin (AZMAC) Immunoglobulin G (IGG, IGG-C*, IGG-U*)
B2-Microglobulin (B2MIC) Immunoglobulin G Subclass 1 (IGG1)
C3 Complement (C3) fmmunoglobulin G Subclass 2 (IGG2)
C4 Complement (C4) Immunoglobulin G Subclass 3 (IGG3)
Ceruloplasmin (CER) Immunoglobulin G Subclass 4 (IGG4)
Haptoglobin (HAPT) Immunoglobulin M (IGM)
Hemopexin (HPX) Prealbumin (PREALB)
Homocysteine (HCYS) Retinol binding Protein (RBP)
lg fight chains, type Kappa (KAPPA) soluble Transferrin Receptor (STFR)
Ig light chains, type Lambda (LAMBDA) Transferrin (TRF)
*For cerebrospinal fluid (CSF)
** For urine
PROTi CON M is an assayed, mid-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vistao System in the quantitative determination of:
a,-Acid Glycoprotein (AlAG) Immunoglobulin E (IGE)
a1-Antitrypsin (AIAT) Immunoglobulin G (IGG, IGG-C*)
a2-Macroglobulin (A2MAC) Immunoqlobulin G Subclass I (IGG1)
P2-Microglobulin (1B2MIC) Imuolbulin G Subclass 2 (IGG2)
03 Complement (03) Imuolbulin G Subclass 3 (IGG3)
04 Complement (C4) Immunoglobulin G Subclass 4 (IGG4)
Ceruloplasmin (CER) Immunoglobulin M ([GM)
Haptoglobin (HAPT) Prealbumin (PREALB)
Hemopexin (HPX) Retinol binding Protein (RBP)
Homocysteine (HCYS) soluble Transferrin Receptor (STFR)
Ig light chains, type Kappa (KAPPA) specialty Albumin (sALB)
Ig light chains, type Lambda (LAMBDA) Transferrin (TRF)
Immunoglobulin A (IGA)
* For serum and plasma
Dimension Vista ® LAMBDA Flex® reagent cartridge:
The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, lambda type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.
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:
a,-Acid Glycoprotein (A1AG) Immunoglobulin E (IGE)
a1 -Antitrypsin (A1AT) Immunoglobulin G (IGG, IGG-C*)
a 2-Macroglobulin (A2MAC) Immunoglobulin G Subclass 1 (IGG1)
C3 Complement (C3) Immunoglobulin G Subclass 2 (IGG2)
C4 Complement (C4) Immunoglobulin G Subclass 3 (IGG3)
Ceruloplasmin (CER) Immunoglobulin G Subclass 4 (IGG4)
Haptoglobin (HAPT) Immunoglobulin M(IGM)
Hemopexin (HPX) Prealbumin (PREALB)
Homocysteine (HCYS) Retinol binding Protein (RBP)
Ig light chains, type Kappa (KAPPA) soluble Transferrin Receptor (STFR)
Ig light chains, type Lambda (LAMBDA) Specialty Albumin (sALB)
Immunoglobulin A (IGA) Transferrin (TRF)
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 Vista® System in the quantitative determination of:
a,-Acid Glycoprotein (AAG) Immunoglobulin E (IGE)
al-Antitrypsin (AlAT) Immunoglobulin G (IGG, IGG-C*)
a 2-Macroglobulin (A2MAC) Immunoglobulin G Subclass 1 (IGG1)
32-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)
Ig light chains, type Kappa (KAPPA) specialty Albumin (sALB)
Ig light chains, type Lambda (LAMBDA) Transferrin (TRF)
Immunoglobulin A (IGA)
* 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/K082503 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082503: Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type Lambda, Dimension Vista Protein 1 Cal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082503
Report an extraction error
Are you the manufacturer?
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