(95 days)
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a1-Acid Glycoprotein (A1AG), a ;- Antitrypsin (A1AT), 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) [serum/plasma], Immunoglobulin G (IGG-C) [cerebrospinal fluid] and Immunoglobulin G (IGG-U) (urine), Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), lmmunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF)
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the determination of α Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C), Immunoglobulin G (IGG-U)** and Microalbumin (MALB). * For Cerebrospinal fluid (CSF) ** For urine
Dimension Vista® System Immunoglobulin G Flex® reagent cartridge: Proteins contained in human body fluids from 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® System Protein 1 Calibrator: PROT1 CAL is a multi-analyte, liquid human serum based product containing: α₁-Acid Glycoprotein, α₁-Antitrypsin, β₂-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, Prealbumin, Retinol Binding Protein, soluble Transferrin Receptor, Transferrin.
Dimension Vista® System Protein 3 Control: PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing: a - Microglobulin, Immunoglobulin G, Albumin.
The provided document is a 510(k) premarket notification for in vitro diagnostic devices, namely the Dimension Vista® System IGG Flex® reagent cartridge, Protein 1 Calibrator, and Protein 3 Control. It states that these devices are substantially equivalent to legally marketed predicate devices. This type of submission does not typically include detailed studies with acceptance criteria and device performance in the format of a clinical trial for an AI/ML medical device. Instead, it focuses on demonstrating analytical performance (e.g., correlation, precision, analytical bias) for a laboratory diagnostic system.
Therefore, the requested information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and how ground truth was established is not present in the provided text.
The document primarily makes claims of substantial equivalence to predicate devices based on intended use and analytical studies, rather than reporting on a clinical effectiveness study with defined acceptance criteria for diagnostic accuracy, sensitivity, or specificity in the way an AI/ML device might.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document states that "studies included in this submission demonstrate correlation to and equivalent performance between the predicate Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G for urine sample matrix and the predicate N Antisera to Human Immunoglobulins (IgG IgA, and IgM) on the BN ProSpec® System for the addition of a pre-reaction step to the Dimension Vista® IGG-C assay."
This indicates that correlation and equivalent performance were the acceptance criteria, but the specific metrics (e.g., correlation coefficient thresholds, mean difference limits) and the resultant device performance values are not detailed in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not provided. The summary mentions "studies" but does not give details about the sample sizes of patients or samples used in these studies, nor their country of origin or whether they were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Provided. For an in vitro diagnostic device measuring immunoglobulin G, the "ground truth" would typically be established by a reference method or known concentrations of analytes in control materials, not by expert interpretation of images or clinical data. Therefore, the concept of "experts" in this context is not relevant.
4. Adjudication Method for the Test Set
Not applicable/Provided. Adjudication methods (e.g., 2+1) are usually relevant for human expert interpretation and resolving discrepancies, which is not pertinent to the analytical performance of an in vitro diagnostic assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are associated with diagnostic imaging or other interpretive tasks where multiple human readers assess cases. This is an IVD device for quantitative measurement, so an MRMC study would not be applicable.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The device is an in vitro diagnostic system designed to quantitatively measure Immunoglobulin G. Its performance is inherently "standalone" in that it processes samples and produces numerical results without human interpretive input into the measurement itself. The "correlation" and "equivalent performance" mentioned would be standalone analytical performance. However, specific metrics are not provided.
7. The Type of Ground Truth Used
Implicitly, reference methods or known concentrations. For an IVD device, the ground truth for performance studies is typically established by:
- Comparison to a legally marketed predicate device (as stated in the conclusion).
- Known concentrations of analytes in control samples or calibrators.
- Reference methods that are considered the gold standard for measuring the analyte.
The document states "correlation to and equivalent performance between the predicate...", suggesting the predicate device's results serve as the ground truth reference for comparison.
8. The Sample Size for the Training Set
Not applicable/Provided. This device is an analytical instrument and reagents, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The "training set" concept is not relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Provided. As mentioned, the concept of a "training set" with established ground truth is not applicable for this type of IVD device.
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ROJII6I
JUL 2 8 2008
510 (k) Summary
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.
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:
Helen M. Lee Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 302.631.8706 302.631.6299 (fax)
Date of Preparation: July 17, 2008
2. Name of Products: Dimension Vista® System IGG Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control
3. Identification of the Legally marketed Device:
Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G (K951635) N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K042735) Dimension Vista® System Protein 1 Calibrator (K073561) Dimension Vista® System Protein 3 Control (K073561)
4. Device Descriptions:
Dimension Vista® System Immunoglobulin G Flex® reagent cartridge
Proteins contained in human body fluids from 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.
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Dimension Vista® System Protein 1 Calibrator
PROT1 CAL is a multi-analyte, liquid human serum based product containing:
| α₁-Acid Glycoprotein | Immunoglobulin G |
|---|---|
| α₁-Antitrypsin | Immunoglobulin G Subclass 1 |
| β₂-Microglobulin | Immunoglobulin G Subclass 2 |
| C3 Complement | Immunoglobulin G Subclass 3 |
| C4 Complement | Immunoglobulin G Subclass 4 |
| Ceruloplasmin | Immunoglobulin M |
| Haptoglobin | Prealbumin |
| Hemopexin | Retinol Binding Protein |
| Homocysteine | soluble Transferrin Receptor |
| Immunoglobulin A | Transferrin |
| Immunoglobulin E |
Dimension Vista® System Protein 3 Control PROT3 CON is a multi-analyte, lyophilized, polygeline and rabbit albumin based product containing:
a - Microglobulin Immunoglobulin G Albumin
5. Device Intended Uses:
Dimension Vista Immunoglobulin G Flex reagent cartridge
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine on the Dimension Vista System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista® System Protein 1 Calibrator
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:
| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin G (IGG) [serum/plasma] |
|---|---|
| Immunoglobulin G (IGG-C) [cerebrospinal fluid] | |
| Immunoglobulin G (IGG-U) [urine] | |
| α₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G Subclass 2 (IGG2) |
| C3 Complement (C3) | Immunoglobulin G Subclass 3 (IGG3) |
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C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)
Immunoqlobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Dimension Vista® System Protein 3 Control
PROT3 CON is an assayed quality control for the assessment of precision and analytical bias on the Dimension Vista System in quantitative determination of:
a -Microglobulin (A1MIC) Immunoqlobulin G (IGG-C)* Immunoglobulin G (IGG-U) ** Microalbumin (MALB) specialty Albumin (sALB) *
- For cerebrospinal fluid (CSF)
** For urine
6. Medical Device to which equivalence is claimed and comparison information:
The Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G was determined to be substantially equivalent in 510(k) Premarket Notification K951635 and is the predicate for adding the urine sample matrix to the previously cleared Dimension Vista® IGG assay.
The N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) on the BN Systems was determined to be substantially equivalent in 510(k) Premarket Notification K042735 and is the predicate for the addition of a pre-reaction step to the previously cleared IGG-C (CSF). The operating principle and reagent composition have not changed. For your convenience, the sections with changes have been highlighted in the Draft Instructions for Use included in this submission.
Dimension Vista® Protein 1 Calibrator, modified to include IGG-U (IGG in urine), is substantially equivalent in intended use to the current Dimension Vista® Protein 1 Calibrator (K073561). The modified Dimension Vista® Protein 1 Calibrator, like the current product, is intended to be used for the calibration of human protein assays on the Dimension Vista® System.
Dimension Vista® System Protein 3 Control modified to include IGG-U (IGG in urine), is substantially equivalent in Intended Use to the current Dimension Vista® System Protein 3 Control (K073561). The modified Dimension Vista® System Protein 3 Control like the current product is intended to be used as an assayed intralaboratory quality control on the Dimension Vista® System.
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7. Conclusion:
The studies included in this submission demonstrate correlation to and equivalent performance between the predicate Beckman Coulter IMMAGE® Immunochemistry System Urine Immunoglobulin G for urine sample matrix and the predicate N Antisera to Human Immunoglobulins (IgG IgA, and IgM) on the BN ProSpec® System for the addition of a pre-reaction step to the Dimension Vista® IGG-C assay.
The modified Dimension Vista® System IGG assay, modified Dimension Vista® System Protein 1 Calibrator and modified Dimension Vista® System Protein 3 Control are substantially equivalent to the legally marketed devices based upon the information above.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Ms. Helen M. Lee Regulatory Affairs and Compliance Manager 500 GBC Drive, MS 514 Newark, DE 19714-6101
JUL 2 8 2008
Re: K081161
Trade/Device Name: Dimension Vista® System Immunoglobulin G Flex® Reagent Cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control Regulation Number: 21 CFR 866.5510 Regulation Name: Immunoglobulins A, G, M, D and E immunological test system Regulatory Class: Class II Product Code: CFN, JIX, JJY Dated: July 2, 2008 Received: July 3, 2008
Dear Ms. Lee:
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.
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
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Page 2 -
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,
Maria 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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Indications for Use Statement
10811 510(k) Number (if known):
Device Name:
Dimension Vista® System Protein 3 Control
Indications for Use:
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the determination of α Microglobulin (A1MIC), specialty Albumin (sALB), Immunoglobulin G (IGG -C), Immunoglobulin G (IGG-U)** and Microalbumin (MALB).
- For Cerebrospinal fluid (CSF) ** For urine
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Maria M Chen
Division Sign-Off
f in Vitro Diagnostic Evaluation and S
510(k) K00/16/
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Indications for Use Statement
K081161 510(k) Number (if known):
Device Name:
Dimension Vista® System Protein 1 Calibrator
Indications for Use:
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:
a1-Acid Glycoprotein (A1AG)
a ;- Antitrypsin (A1AT) 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) [serum/plasma], Immunoglobulin G (IGG-C) [cerebrospinal fluid] and Immunoglobulin G (IGG-U) (urine) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
mchan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081161
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K081161 510(k) Number (if known):
Device Name:
Dimension Vista® System Immunoglobulin G Flex® Reagent cartridge
Indications for Use:
The IGG method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin G in human serum, heparinized plasma, cerebrospinal fluid (CSF) and urine on the Dimension Vista® System. Measurements of IgG aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Thora In chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and S
570K Kof. 1161
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).