(109 days)
Not Found
No
The device description details a standard immunochemical reaction and light scattering measurement, evaluated by comparison to a known standard. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The provided text clearly states that the B2MIC method is an "in vitro diagnostic test" and describes it as a reagent cartridge and calibrators/controls used for quantitative measurement of substances in human body fluids, which are characteristics of diagnostic devices, not therapeutic ones.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The B2MIC method is an in vitro diagnostic test..." and further notes that "Measurement of ß2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease."
No
The device description clearly outlines physical components like reagent cartridges, calibrators, and controls, which are used with a Dimension Vista® System (a hardware analyzer). This indicates it is not a software-only device.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section for the B2MIC method, PROT1 CAL, PROT1 CON L, and PROT1 CON M all explicitly state that they are "in vitro diagnostic" products.
- Purpose of the Device: The descriptions clearly indicate that the device and its associated components are used to measure specific substances (like ß₂-microglobulin and various proteins) in human body fluids (serum, plasma, urine, cerebrospinal fluid) to aid in the diagnosis of diseases (rheumatoid arthritis, kidney disease). This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Components are IVD Products: The calibrators and controls (PROT1 CAL, PROT1 CON L, PROT1 CON M) are also described as "in vitro diagnostic products" and are essential for the proper functioning and quality control of the B2MIC assay, which is itself an IVD.
Therefore, the text provides clear and repeated evidence that this device and its associated components are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
Dimension Vista® B2MIC Flex® reagent cartridge: The B2MU method is an in vitro diagnostic test for the quantitative measurement of ß₂microglobulin in human serum, heparinized plasma, EDTA plasma and urine using the B2MIC Flex® reagent cartridge on the Dimension Vista® Systems. Measurement of ß 2 -microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Dimension Vista® PROT 1 CAL: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: αγ-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), IS2-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*, ICC-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
** 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: α-Acid Glycoprotein (A1AG), α-- Antitrypsin (A1AT), a2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC-U ), 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), Immunodlobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB), soluble Transferrin Receptor (STFR) and Transferrin (TRF).
For serum and plasma
** For Urine
Dimension Vista® Protein 1 Control M: PROT1 CON M is an assayed, mid-level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: : α -- Acid Glycoprotein (A1AG), α -- Antitrypsin (A1AT), α 2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC,B2MIC-U), 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), lmmunoqlobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF),
*For serum and plasma
** For urine
Product codes
JZG, JIX, JJY
Device Description
Dimension Vista® B2MIC 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: a+acid glycoprotein, a1 -antitrypsin, a1-macroglobulin, 132 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunodlobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, 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 :
q-acid glycoprotein, α-- antitrypsin, α 2-macroglobulin, ß-microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoqlobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealburnin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M: Protein 1 Control M is a multi-analyte, mid level, liquid human serum based product containing: Q -- acid glycoprotein, a -- antitrypsin, as -macroglobulin, 13-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3. immunodobulin G subclass 4. immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Method Comparison Study: The Dimension Vista® B2MU assay was compared to the N Latex to Human ß ₂-microglobulin on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 0.022 – 0.553 mg/dL (0.223 – 5.53mg/L). Regression analysis of these results yielded the following equation: Slope 0.952, Intercept -0.0008 (-0.008), Correlation Coefficient 0.988, n 82.
Key Metrics
Correlation Coefficient 0.988
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
Ko 83463
MAR. 1, 2009
510(k) Summary for
Dimension Vista® B2MIC Flex® reagent cartridge
Dimension Vista® Protein 1 Calibrator
Dimension Vista® Protein 1 Control L and M
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.
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer: Siemens Healthcare Diagnostics Products
Emil-von-Behring Str. 76
35041 Marburg, Germany
Contact Information: Siemens Healthcare Diagnostics.
500 GBC Drive, M/S 514
Newark, Delaware 19702
Attn: Anna Marie Kathleen Ennis
Tel: 302-632-9352
Fax: 302-631-6299
Preparation date: February 4, 2009
- Device Name:
Dimension Vista® B2MIC Flex® reagent cartridge
Dimension Vista® PROT 1 CAL
Dimension Vista® PROT 1 CON L and M
Classification: Class II; Class II; Class I
Product Code: JZG, JIX, JJY
Panel: Immunology (82) and Clinical Chemistry (75)
3. Identification of the Legally Marketed Devices:
Siemens N Latex ß2- microglobulin - K002731
1
N Protein Standard SL - K052788
N/T Protein Controls SL - K052788
4. Device Descriptions:
Dimension Vista® B2MIC 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: a+acid glycoprotein, a1 -antitrypsin, a1-macroglobulin, 132 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunodlobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, 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 :
q-acid glycoprotein, α-- antitrypsin, α 2-macroglobulin, ß-microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoqlobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealburnin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M
Protein 1 Control M is a multi-analyte, mid level, liquid human serum based product containing: Q -- acid glycoprotein, a -- antitrypsin, as -macroglobulin, 13-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3. immunodobulin G subclass 4. immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.
5. Device Intended Uses
Dimension Vista® B2MIC Flex® reagent cartridge:
The B2MU method is an in vitro diagnostic test for the quantitative measurement of ß₂microglobulin in human serum, heparinized plasma, EDTA plasma and urine using the B2MIC Flex® reagent cartridge on the Dimension Vista® Systems. Measurement of ß 2 -microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Dimension Vista® PROT 1 CAL:
2
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: αγ-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), IS2-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*, ICC-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
** 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: α-Acid Glycoprotein (A1AG), α-- Antitrypsin (A1AT), a2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC-U *), 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), Immunodlobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB), soluble Transferrin Receptor (STFR) and Transferrin (TRF).
*For serum and plasma
** For Urine
Dimension Vista® Protein 1 Control M
PROT1 CON M is an assayed, mid-level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: : α -- Acid Glycoprotein (A1AG), α -- Antitrypsin (A1AT), α 2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC*,B2MIC-U**), 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), lmmunoqlobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF),
*For serum and plasma
** For urine
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista® B2MJC Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L and M, are substantially equivalent to the Siemens N Latex ßz-microglobulin assay (K002731), N/T Protein Standard SL (K052788) and N Protein Controls SL (K052788). The Dimension Vista® B2MIC assay, like Siemens N Latex (1 2-microglobulin assay is an in vitro diagnostic test for the quantitative measurement of ß2 -microglobulin in human serum, plasma and urine.
7. Device Performance Characteristics:
3
Method Comparison Study
The Dimension Vista® B2MU assay was compared to the N Latex to Human ß ₂-microglobulin on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 0.022 – 0.553 mg/dL (0.223 – 5.53mg/L). Regression analysis of these results yielded the following equation:
| Comparative
Method | Slope | Intercept
mg/dL (mg/L) | Correlation
Coefficient | n |
|------------------------------------|-------|---------------------------|----------------------------|----|
| β₂-microglobulin
on BN Prospec® | 0.952 | -0.0008 (-0.008) | 0.988 | 82 |
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Seimens Healthcare Diagnostics Inc. c/o Ms. Anna Marie Kathleen Ennis Senior Regulatory Affairs and Compliance Specialist 500 GBC Drive P.O. Box 601 Newark, DE 19714-6101 US
MAR 1 3 2009
Re: K083463
Trade/Device Name: Dimension Vista® B2MIC Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L
Dimension Vista® Protein 1 Control M
Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-microglobulin immunological test system Regulatory Class: Class II Product Code: JZG, JIX, JJY Dated: February 4, 2009 Received: February 5, 2009
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.
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
5
Page 2 - Ms. Anna Marie Kathleen Ennis
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 vours.
' mchen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known): KO83463
Device Name: Dimension Vista® B2MIC Flex Reagent Cartridge
Indication for Use:
The B2MIC method is an in vitro diagnostic test for the quantitative measurement of ß2-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.
Prescription Use _ X
And/Or
Over the Counter Use
(21 CFR Part 801
(21 CFR Part 801 Subpart D) Subpart C)
(Please Do Not WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OMD)---
Maria In Chain
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kofs463
Page 1 of 1
7
Indications for Use
510(k) Number (if known): Kod3 4 63
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 G (IGG) |
|---|---|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 2 (IGG2) |
| β₂-Microglobulin (B2MIC, B2MU**) | Immunoglobulin G Subclass 3 (IGG3) |
| C3 Complement (C3) | Immunoglobulin G Subclass 4 (IGG4) |
| C4 Complement (C4) | Immunoglobulin M (IGM) |
| Ceruloplasmin (CER) | Prealbumin (PREALB) |
| Haptoglobin (HAPT) | Retinol binding Protein (RBP) |
| Hemopexin (HPX) | soluble Transferrin Receptor (STFR) |
| Homocysteine (HCYS) | specialty Albumin (sALB*) |
| Immunoglobulin A (IGA) | Transferrin (TRF) |
| Immunoglobulin E (IGE) |
- For serum and plasma
** For urine
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
Page 1 of
Maria M'Chen.
Division Slan-
Office of In Vitro Diagnostic Device Evaluation and Safety
5100
8
Indications for Use
510(k) Number (if known): Ko 8 346 3
Device Name:
- For Urine
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) a1-Antitrypsin (A1AT) a2- Macroglobulin (A2MAC) B2-Microglobulin (B2MIC, B2MU**) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) * For cerebrospinal fluid (CSF)
Immunoglobulin E (IGE) Immunoqlobulin 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) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)
Prescription Use × (Per 21 CFR 801 Subpart D)
Over-The-Counter-Use AND/OR (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
ia m chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083463
9
Indications for Use
510(k) Number (if known): Ko83463
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:
| a₁-Acid Glycoprotein (A1AG) | Immunoglobulin G (IGG) |
|---|---|
| a₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 2 (IGG2) |
| β₂-Microglobulin (B2MIC, B2MU**) | Immunoglobulin G Subclass 3 (IGG3) |
| C3 Complement (C3) | Immunoglobulin G Subclass 4 (IGG4) |
| C4 Complement (C4) | Immunoglobulin M (IGM) |
| Ceruloplasmin (CER) | Prealbumin (PREALB) |
| Haptoglobin (HAPT) | Retinol binding Protein (RBP) |
| Hemopexin (HPX) | soluble Transferrin Receptor (STFR) |
| Homocysteine (HCYS) | specialty Albumin (sALB*) |
| Immunoglobulin A (IGA) | Transferrin (TRF) |
| Immunoglobulin E (IGE) |
- For serum and plasma
** For urine
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
Page 1 of
Maria M Chan
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety