(80 days)
Not Found
No
The summary describes an in vitro diagnostic test and associated reagents/calibrators/controls that use immunochemical reactions and light scattering to measure protein concentrations. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an "in vitro diagnostic " used for "quantitative measurement" to support "diagnosis" of certain disorders, rather than directly treating or mitigating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Dimension Vista® A2MAC Flex® reagent cartridge is "an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma" and that "Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders." This directly indicates its use for diagnostic purposes. Furthermore, the other listed items (calibrators and controls) are "in vitro diagnostic product[s]" used with the system.
No
The device description clearly indicates that the device includes physical components such as reagent cartridges, calibrators, and controls, which are used in an immunochemical reaction on a Dimension Vista® System. This is not a software-only device.
Based on the provided text, all of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statements: The "Intended Use / Indications for Use" section for each product explicitly states that they are "in vitro diagnostic test" or "in vitro diagnostic product".
- Nature of the Tests: The descriptions clearly indicate that these devices are used to measure substances (proteins, etc.) in human body fluids (serum, plasma, cerebrospinal fluid) to aid in the diagnosis or assessment of medical conditions (blood clotting or lysis disorders, precision and analytical bias in quantitative determination of various proteins). This aligns 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.
- Device Description: The device descriptions further support this by explaining how the tests work on biological samples (immunochemical reactions, scattering of light, use of human serum-based products).
Therefore, the Dimension Vista® A2MAC Flex® reagent cartridge, Dimension Vista® PROT 1 CAL, Dimension Vista® Protein 1 Control L, and Dimension Vista® Protein 1 Control M and H are all IVDs.
N/A
Intended Use / Indications for Use
Dimension Vista® A2MAC Flex® reagent cartridge: The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System. Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.
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), a-Antitrypsin (A1AT), α2-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*), 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
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), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma
Dimension Vista® Protein 1 Control M and H: PROTI 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), a]-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), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF). *For serum and plasma
Product codes (comma separated list FDA assigned to the subject device)
DEB, JIX, JJY
Device Description
Dimension Vista® A2MAC 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; ar-acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2 -microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E,, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin 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 : a1-acid glycoprotein, a1-antitrypsin, a2 -macroglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2. immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein,homocysteine, 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 scrum based products containing: aj -acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2-microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G Subclass . immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin 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
human serum and plasma, cerebrospinal fluid (CSF)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study: The Dimension Vista® A2MAC assay was compared to the N Antisera to Human anmacroglobulin on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 28 - 637 mg/dL (0.28 - 6.37 g/L). Regression analysis of these results yielded the following equation: Slope 1.042, Intercept +6.3 mg/dL [+0.063] g/L, Correlation Coefficient 0.993, n 143.
Conclusion: These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human a2-Macroglobulin assay and the Dimension Vista® A2MAC assay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient 0.993
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5620
Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(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
K0812'19
JUL 2 1 2008
510(k) Summary for
Dimension Vista® A2MAC Flex® reagent cartridge
Dimension Vista® Protein 1 Calibrator
Dimension Vista® Protein 1 Control L,M,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: K081249
- 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: 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: April 28, 2008
2. Device Name:
Dimension Vista® A2MAC Flex® reagent cartridge
Dimension Vista® PROT 1 CAL
Dimension Vista® PROT 1 CON, L.M.H
Classification: Class II; Class II; Class I Product Code: DEB, JIX, JJY
Panel: Immunology (82) and Clinical Chemistry (75)
3. Identification of the Legally Marketed Devices:
Dade Behring N Antisera to Human a2- macroglobulin - K053073
N Protein Standard SL - K012470
N/T Protein Controls SL - K012468
4. Device Descriptions:
Dimension Vista® A2MAC 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
1
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; ar-acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2 -microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E,, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin 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 :
a1-acid glycoprotein, a1-antitrypsin, a2 -macroglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2. immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein,homocysteine, 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 scrum based products containing: aj -acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G Subclass . immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.
5. Device Intended Uses
Dimension Vista® A2MAC Flex® reagent cartridge:
The A2MAC method is an in vitro diagnostic test for the quantitative measurement of amacroglobulin in human serum and plasma on the Dimension Vista® Systems. Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.
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), a-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*), 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
2
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), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF).
*For serum and plasma
Dimension Vista® Protein 1 Control M and H
PROTI 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), a]-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), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF).
*For serum and plasma
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista® A2MAC Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L, M, H are substantially equivalent to the Dade Behring N Antisera to Human a2 –macroglobulin assay (K053073), N/T Protein Standard SL (K012470) and N Protein Controls SL (K012468). The Dimension Vista® A2MAC assay, like Dade Behring N Antisera to Human a2-macroglobulin assay is an in vitro diagnostic test for the quantitative measurement of a2 ~macroglobulin in human serum and plasma.
7. Device Performance Characteristics:
The Dimension Vista® A2MAC assay was compared to the Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 28 - 637 mg/dL. Regression analysis of these results vielded the following equation.
Method Comparison Study
The Dimension Vista® A2MAC assay was compared to the N Antisera to Human anmacroglobulin on the BN ProSpec® System by evaluating serum and plasma samples with concentrations ranging from 28 - 637 mg/dL (0.28 - 6.37 g/L). Regression analysis of these results yielded the following equation:
3
| Comparative Method | Slope | Intercept
mg/dL [g/L] | Correlation
Coefficient | n |
|-----------------------------------------------|-------|--------------------------|----------------------------|-----|
| α2-macroglobulin on the
BN ProSpec® System | 1.042 | +6.3 [+0.063] | 0.993 | 143 |
8. Conclusion:
These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human a2-Macroglobulin assay and the Dimension Vista® A2MAC assay.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 1 2008
Siemens Healthcare Diagnostics c/o Ms. Anna Marie K. Ennis Sr. regulatory Affairs and Compliance Specialist 500 GBC Drive M/S 514 Newark, DE 19714-6101
Re: K081249
Trade/Device Name: Dimension Vista® A2MAC 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 866.5620 Regulation Name: Alpha-2-macroglobulin antigen, antiserum, control Regulatory Class: Class II
Product Code: DEB, JIX, JJY Dated: May 1, 2008
Received: May 2, 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
5
Page 2 --
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing vour 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" (21 CFR 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,
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
6
510(k) Number (if known): Ko & / > 4 9
Dimension Vista® A2MAC Flex® reagent cartridge Device Name:
Indications For Use:
Dimension Vista® A2MAC Flex® reagent cartridge:
The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® System. Measurements of α2-macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
ve m chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation cu
510(k) K081249
7
510(k) Number (if known): JaO8 /2 49
Dimension Vista® PROT 1 CAL Device Name:
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:
a - Acid Glycoprotein (A 1AG) a1-Antitrypsin (A1AT) α2-Macroglobulin (Α2ΜΑC) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoqlobulin A (IGA) * For cerebrospinal fluid (CSF) Immunoglobulin E (IGE) Immunoglobulin G (IGG, IGG-C*) 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)
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter-Use (21 CFR 801 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Page 1 of
Marie M Chan
Office of In Vitro Diagnostic Device Evaluation and Safely
510(k) K0d1249
8
510(k) Number (if known): Ko 8/2 49
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:
a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) a2-Macroglobulin (A2MAC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) * For serum and plasma
× --Prescription Use (Per 21 CFR 801 Subpart D)
Retinol binding Protein (RBP) soluble Transferrin Receptor (STFR) specialty Albumin (sALB*) Transferrin (TRF)
Immunoglobulin G (IGG)
İmmunoglobulin M (IGM) Prealbumin (PREALB)
Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2)
Immunoglobulin G Subclass 3 (IGG3)
Immunoglobulin G Subclass 4 (IGG4)
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
Page 1 of
mchan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081249
9
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 G (IGG) |
|---|---|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 2 (IGG2) |
| β₂-Microglobulin (B2MIC) | 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
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
Page 1 of
Maria M Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Saft
510(k) K081249
10
510(k) Number (if known):
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:
| a₁-Acid Glycoprotein (A1AG) | Immunoglobulin G (IGG) |
|---|---|
| a₁-Antitrypsin (A1AT) | Immunoglobulin G Subclass 1 (IGG1) |
| a₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 2 (IGG2) |
| B₂-Microglobulin (B2MIC) | 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
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
Page 1 of
·
Maria McHan
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K081249