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® 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

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

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, 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® A2MAC Flex® reagent cartridge:

The document describes a medical device, the Dimension Vista® A2MAC Flex® reagent cartridge, and its associated calibrator and controls, which are intended for the quantitative measurement of alpha-2-macroglobulin (A2MAC) in human serum and plasma. The study presented is a method comparison study to demonstrate substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Correlation coefficient close to 1.0	0.993
Slope close to 1.0	1.042
Intercept close to 0 (or a clinically acceptable bias)	+6.3 mg/dL [+0.063 g/L]
Demonstrates correlation and equivalent performance	"These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human a2-Macroglobulin assay and the Dimension Vista® A2MAC assay."

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, in method comparison studies for substantial equivalence, the implicit acceptance criteria are typically a slope statistically close to 1, an intercept statistically close to 0, and a high correlation coefficient (usually >0.975 or >0.98, depending on the analyte and regulatory guidance). The reported performance (slope 1.042, intercept +6.3 mg/dL, correlation 0.993) is stated to demonstrate correlation and equivalent performance. The context of a 510(k) submission implies that these results met the FDA's unstated (or internal) acceptance criteria for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 143 samples (n=143)
Data Provenance: The data used were human serum and plasma samples, with concentrations ranging from 28 - 637 mg/dL. The document does not specify the country of origin or whether the samples were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not utilize experts to establish ground truth in the way an imaging or diagnostic algorithm might. Instead, the "ground truth" for each sample is the quantitative value obtained from the predicate device (Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System). This is a comparison between two instruments/reagents, not a subjective interpretation.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study compares quantitative measurements from two automated systems. There is no human adjudication process involved in establishing the "ground truth" for the test set or for managing discrepancies between human readers.

5. 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, an MRMC comparative effectiveness study was not conducted. This study compares the performance of a new in vitro diagnostic reagent and system to a predicate device, not the performance of human readers or the impact of AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is a standalone performance study of the Dimension Vista® A2MAC assay. The comparison is between the new device and the predicate device, both operating as automated systems without direct human interpretation in the results generation. Human involvement is limited to sample handling, instrument operation, and data analysis, not diagnostic interpretation of raw data for each test.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for comparison was the quantitative measurement obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System. This is a reference method comparison.

8. The Sample Size for the Training Set

The document does not specify a training set or its size. This is common for traditional in vitro diagnostic device submissions like this one, as they typically involve analytical performance validation (e.g., method comparison, precision, accuracy) rather than machine learning algorithm development which requires distinct training, validation, and test sets. The assay, calibrator, and controls are likely developed and optimized internally by the manufacturer, but the specific "training set" in an AI/ML context is not disclosed or applicable here.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a distinct "training set" with established ground truth in the context of an AI/ML device is not mentioned or relevant to this type of traditional IVD submission. The assay's performance characteristics (linearity, sensitivity, etc.) would have been established during its development using internal methods, but this is not equivalent to "ground truth establishment for a training set" as understood in AI/ML validation studies.

Summary

{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	Interceptmg/dL [g/L]	CorrelationCoefficient	n
α2-macroglobulin on theBN 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

Regulation Number and Section

§ 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.