(112 days)
Dimension Vista® KAPPA Flex® reagent cartridge: The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the different types of light chains aid 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® LAMBDA Flex® reagent cartridge: The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the differant types of light chains aid in the diagnosis of multiple myeloma cancer of antibody-forming cells) lymphocytic neoplasms ( cancer of lymohoid tissue), Waldenstom'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® Systems for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), 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 light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunglobulin (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF) *For cerebrospinal fluid ** For urine
Dimension Vista® Protein 1 Control L: PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -Macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ccruloplasmin (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 light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma
Dimension Vista® Protein 1 Control M and H: PROT1 CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a2-Macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), 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), lmmunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF). *For scrum and plasma
Dimension Vista® KAPPA Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® LAMBDA Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a1acid glycoprotein, a1 -antitrypsin, az- macroglobulin,b2-microglobulin, C3 complement, C4 complement, ccruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1 -antitrypsin, a-- macroglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, i mmunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing: a1 -acid glycoprotein, a1 -antitrypsin, a2macroglobulin, b2 -Microglobulin (B2MIC), C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M. immunoglobulin light chains type kappa, immunoglobulin light chains type lambda. prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
Here's a breakdown of the acceptance criteria and study details for the Dimension Vista® KAPPA Flex® and LAMBDA Flex® reagent cartridges, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Dimension Vista® KAPPA Flex® and LAMBDA Flex® reagent cartridges are implicitly established by their comparison to legally marketed predicate devices. The study aims to demonstrate substantial equivalence, meaning the new device performs comparably to the existing devices. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient or defined acceptable slope/intercept ranges) aren't directly stated as "acceptance criteria," the reported performance metrics (slope, intercept, correlation coefficient) are the basis for demonstrating this equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Performance History) | Dimension Vista® KAPPA Flex® Performance | Dimension Vista® LAMBDA Flex® Performance |
|---|---|---|---|
| Slope | Demonstrated substantial equivalence to predicate device | 1.105 | 1.045 |
| Intercept | Demonstrated substantial equivalence to predicate device | -4.2 mg/dL [-0.042 g/L] | -1.5 mg/dL [-0.015 g/L] |
| Correlation | Demonstrated substantial equivalence to predicate device | 0.998 | 0.993 |
Note: The acceptance criteria are "demonstrated substantial equivalence." The reported performance metrics are what the manufacturer presented to show this equivalence. In submissions like this, a high correlation coefficient (close to 1) and a slope close to 1 with an intercept close to 0 typically indicate good agreement and thus substantial equivalence.
Study Details
Here's the information regarding the study:
-
Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 66 serum samples for the KAPPA assay and 66 serum samples for the LAMBDA assay.
- Data Provenance: Not explicitly stated regarding country of origin. The study is retrospective as it involves evaluating existing serum samples that covered a range of concentrations.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth appears to be the results obtained from the predicate devices, not an expert panel reviewing cases.
-
Adjudication method for the test set:
- None described. The comparison is directly between the new device's readings and the predicate device's readings.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic reagent cartridge, not an AI-assisted diagnostic tool that involves human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The performance reported is that of the Dimension Vista® KAPPA and LAMBDA assays themselves, operating independently to measure immunoglobulin light chains in serum samples.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for correlation and equivalence purposes was the measurements obtained from the legally marketed predicate devices:
- Dade Behring N Antisera to Human Immunoglobulin/L-chains, kappa type assay on the BN ProSpec® System (for KAPPA)
- Dade Behring N Antisera to Human Immunoglobulin/L-chains, lambda type assay on the BN ProSpec® System (for LAMBDA)
- The "ground truth" for correlation and equivalence purposes was the measurements obtained from the legally marketed predicate devices:
-
The sample size for the training set:
- This information is not provided in the document. For in vitro diagnostic reagents, there might not be a "training set" in the sense of machine learning algorithms. Instead, method development and optimization would occur using various samples, but these are typically not documented as a formalized "training set" with a specific size in 510(k) summaries.
-
How the ground truth for the training set was established:
- Not applicable as the concept of a "training set" with established ground truth in the context of this type of diagnostic reagent study is not detailed. Method development relies on established analytical techniques and reference methods, but the specific validation of a "training set ground truth" is not a typical component of these summaries.
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Korsosoz
510(k) Summary for
DEC 1 9 2008
Dimension Vista® KAPPA Flex® reagent cartridge
Dimension Vista® LAMBDA Flex® reagent cartridge
Dimension Vista® Protein 1 Calibrator
Dimension Vista® Protein 1 Control L, M and H
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer: Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
35041 Marburg, Germany
Contact Information: Sicmens Healthcare Diagnostics.
500 GBC Drive, M/S 514
Newark, Delaware 19702
Attn: Anna Marie Kathleen Ennis
Tcl: 302-632-9352
Fax: 302-631-6299
Preparation date: August 27, 2008
- Device Name:
Dimension Vista® KAPPA Flex® reagent cartridge Dimension Vista® LAMBDA Flex® reagent cartridge
Dimension Vista® PROT 1 CAL
Dimension Vista® PROT 1 CON, L, M and H
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Classification: Class II; Class II; Class I
Product Code: DEH, DFH, JIX, JJY
Panel: 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. Device Descriptions:
Dimension Vista® KAPPA Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® LAMBDA Flex® reagent cartridge
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista® Protein 1 Calibrator
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a1acid glycoprotein, a1 -antitrypsin, az- macroglobulin,b2-microglobulin, C3 complement, C4 complement, ccruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Dimension Vista® Protein 1 Control L
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Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1 -antitrypsin, a-- macroglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, i mmunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M and H
Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing: a1 -acid glycoprotein, a1 -antitrypsin, a2macroglobulin, b2 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M. immunoglobulin light chains type kappa, immunoglobulin light chains type lambda. prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
5. Device Intended Uses
Dimension Vista® KAPPA Flex® reagent cartridge:
The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the different types of light chains aid 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® LAMBDA Flex® reagent cartridge:
The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the differant types of light chains aid in the diagnosis of multiple myeloma cancer of antibody-forming cells) lymphocytic neoplasms ( cancer of lymohoid tissue), Waldenstom'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® Systems for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -macroglobulin
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(A2MAC), b2 -Microglobulin (B2MIC), 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 light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunglobulin (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF)
*For cerebrospinal fluid
** For urine
Dimension Vista® Protein 1 Control L
PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -Macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ccruloplasmin (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 light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF).
*For serum and plasma
Dimension Vista® Protein 1 Control M and H
PROT1 CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a2-Macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), 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), lmmunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF).
*For scrum and plasma
{4}------------------------------------------------
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista® KAPPA Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L, M and H are substantially equivalent to the Dade Behring N Antisera to Human Immunoglobulin/L-chains assay (K860894), N/T Protein Standard SL (K012470) and N Protein Controls SL (K012468). The Dimension Vista® KAPPA assay, like Dade Behring N Antisera to Human Immunoglobulin/Lchains, kappa type assay is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum.
The Dimension Vista® LAMBDA Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L, M and H are substantially equivalent to the Dade Behring N Antisera to Human Immunoglobulin/1-chains assay (K860894), N/T Protein Standard SL (K012470) and N Protein Controls SL (K012468). The Dimension Vista® LAMBDA assay, like Dade Bchring N Antisera to Human Immunoglobulin/Lchains lambda type assay is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human scrum.
7. Device Performance Characteristics:
The Dimension Vista® KAPPA assay was compared to the Dade Behring N Antisera to Human Immunoglobulin/L-chains, kappa type assay on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 31 - 863 mg/dL (0.31 - 8.63 g/L).
Regression analysis of these results vielded the following :
| Comparative Method | Slope | Intercept | CorrelationCoefficient(r) | n |
|---|---|---|---|---|
| mg/dL [g/L] | ||||
| Immunoglobulin/L-chains, kappa type onBN Prospec® System | 1.105 | - 4.2 [-0.042] | 0.998 | 66 |
The Dimension Vista® LAMBDA assay was compared to the Dade Behring N Antisera to Human Immunoglobulin/L-chains, lambda type assay on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 24-401 mg/dL (0.24 -4.01g/L).
Regression analysis of these results yielded the following :
| ComparativeMethod | Slope | Intercept | CorrelationCoefficient | n |
|---|---|---|---|---|
| mg/dL [g/L] | (r) | |||
| Immunoglobulin/L-chains, lambda type | 1.045 | - 1.5 [-0.015] | 0.993 | 66 |
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on BN Prospec® System
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Immunoglobulin/L-chains, kappa type assay and the Dimension Vista® KAPPA assay; and between the Dade Behring N Antisera to Human Immunoglobulin/L-chains, lambda type assay and the Dimension Vista® LAMBDA assay.
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing strokes, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2008
Siemens Healthcare Diagnostics c/o Ms. Anna Marie Kathleen Ennis Senior Regulatory Affairs and Compliance Spec. 500 GBC Drive P.O. Box 6101 Newark, DE, 19741-6101
(
Re: K082503 Trade/Device Name: Dimension Vista® KAPPA Flex® reagent cartridge Dimension Vista® LAMBDA Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control H Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (Light Chain Specific) Immunological Tcst system Regulatory Class: Class II Product Code: DEH, DFH, JIX, JJY Dated: December 4, 2008 Received: December 8, 2008
Dear Ms. Ennis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Siemens Healthcare Diagnostics
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
ia m chan
Maria M. Chan. Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Dimension Vista® KAPPA Flex® reagent cartridge Device Name:
Indications For Use:
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.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Joughine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K08
{9}------------------------------------------------
510(k) Number (if known): K082503
Device Name: Dimension Vista® PROT 1 CAL
Indications For Use:
Dimension Vista® PROT 1 CAL:
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a1-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA) a1-Antitrypsin (A1AT) Immunoglobulin E (IGE) a2- Macroglobulin (A2MAC) Immunoglobulin G (IGG, IGG-C*, IGG-U**) B2-Microglobulin (B2MIC) 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) lmmunoglobulin 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) Transferrin (TRF) *For cerebrospinal fluid (CSF) ** For urine
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Josephine Bautista
vision Sign Off
of In Vitro Diagnostic Device icn and Sa
K of 2503
{10}------------------------------------------------
510(k) Number (if known):
Dimension Vista® PROT 1 CON M Device Name:
Indications For Use:
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:
| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin E (IGE) |
|---|---|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G (IGG, IGG-C*) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 1 (IGG1) |
| β₂-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
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
| Page 1 of | Concurrence of CDRH, Office of Device Evaluation |
|---|---|
| ----------- | -------------------------------------------------- |
Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
| 510(k) | K082503 |
|---|---|
| -------- | --------- |
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510(k) Number (if known):
Dimension Vista® LAMBDA Flex® reagent cartridge Device Name:
Indications For Use:
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.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation
Jorphine Bautton
Division Sign-Off
Office of In Vitro Diagnostic Device Craluation and Safety
{12}------------------------------------------------
510(k) Number (if known):
Dimension Vista® PROT 1 CON L Device Name:
Indications For Use:
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:
| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin E (IGE) |
|---|---|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G (IGG, IGG-C*) |
| α₂-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) |
AND/OR
- For serum and plasma
Prescription Use × (Per 21 CFR 801 Subpart D)
Over-The-Counter-Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Page 1 of
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Saf-
{13}------------------------------------------------
510(k) Number (if known): k 082503
Dimension Vista® PROT 1 CON H Device Name:
Indications For Use:
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:
| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin E (IGE) |
|---|---|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G (IGG, IGG-C*) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 1 (IGG1) |
| β₂-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
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation
Josephine Bautista
ce of In Vitro Diagnostic Device luation and Safe
§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. 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.(b)
Classification. Class II (performance standards).