Dimension Vista® Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista" System for: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) Bo-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) Immunoqlobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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® System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) 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) Transferrin (TRF)

Dimension Vista® Protein 1 Control M and H: PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-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) Immunoglobulin G Subclass 1 (IGG1) İmmunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

Device Description

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a - acid glycoprotein immunoglobulin G a - antitrypsin immunogiobulin G Subclass 1 B »- microalobulin immunoglobulin G Subclass 2 C3 complement immunoglobulin G Subclass 3 C4 complement immunoglobulin G Subclass 4 ceruloplasmin immunoqlobulin M haptoglobin prealbumin hemopexin retinol binding protein homocysteine soluble transferrin receptor immunoglobulin A transferrin immunoglobulin E

Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a-acid glycoprotein a 1-antitrypsin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E immunoqlobulin G immunoglobulin G Subclass 1 immunoglobulin G Subclass 2 immunoqlobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin

Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing : a1-acid glycoprotein a-antitrypsin B2-microglobulin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E immunoglobulin G immunoqlobulin 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

AI/ML Overview

Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1 and Dimension Vista™ Protein 1 Control 510(k) Notification

This document describes the 510(k) summary for the Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L, M, and H. These are in vitro diagnostic products used for the calibration and quality control of various protein assays on the Dimension Vista System. The summary focuses on the substantial equivalence to a previously marketed device (K063663), which was modified to include additional analytes.

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics (e.g., precision, accuracy, linearity studies). Instead, it relies on the concept of "substantial equivalence" to a legally marketed predicate device. The primary claim of equivalence is that the modified devices (including hemopexin, immunoglobulin G subclasses 1-4, and retinol binding protein) are substantially equivalent in intended use to the current Dimension Vista Protein 1 Calibrator and Control L, M, and H (K063663).

The "reported device performance" is implicitly that the modified devices will perform comparably to the predicate devices for their stated intended uses (calibration and quality control) for all listed analytes.

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

The document does not provide details on specific sample sizes for a test set, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective) for any performance studies. The submission focuses on the modifications to an existing device and claims substantial equivalence.

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

Not applicable. This type of information is generally relevant for devices that involve human interpretation or diagnostic capabilities. For a calibrator and control product, the "ground truth" would typically be established through analytical reference methods and certified reference materials, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a test set requiring adjudication in the context of human interpretation.

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:

Not applicable. This device is a calibrator and control product for an automated in vitro diagnostic system, not an AI-based diagnostic tool that assists human readers.

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

Not applicable. This device is a component used with a larger automated system, not a standalone algorithm.

7. The Type of Ground Truth Used:

For a calibrator and control, the "ground truth" for the analytes within the product would be established by:

Reference Methods: Highly accurate and precise analytical methods used to assign values to the constituents of the calibrator and control materials.
Certified Reference Materials (CRMs): Materials with analytically established values traceable to international standards.
Internal Validation and Characterization: Rigorous testing and characterization of the raw materials and final product to determine the concentration and stability of each analyte.

The document does not explicitly detail the specific ground truth methods for the initial predicate device (K063663) or for the newly added analytes in the modified device. However, given the nature of these products, it can be inferred that such analytical methods were employed.

8. The Sample Size for the Training Set:

Not explicitly stated. This information is typically relevant for machine learning or AI-based devices. For a calibrator and control product, a "training set" doesn't apply in the same way. The development and characterization of these products involve extensive analytical testing and formulation development.

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

Not explicitly stated, as the concept of a "training set" in the context of AI is not applicable here. The "ground truth" for the product itself (i.e., the known concentrations of the analytes within the calibrator and control materials) would have been established through the analytical methods mentioned in point 7.

Summary

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1 and Dimension Vista™ Protein 1 Control 510(k) Notification

SEP 1 1 2007

510(k) Summary for Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L, M and H

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:

Manufacturer:	Dade Behring Marburg GmbHEmil-von-Behring Str. 7635041 Marburg, Germany
Contact Information:	Dade Behring Inc.P.O. Box 6101Newark, Delaware 19714-6101Attn: A. Kathleen EnnisTel: 302-631-9352Fax: 302-631-6299
Preparation date:	June 8, 2007
Device Name:	Dimension Vista® Protein 1 CalibratorDimension Vista® Protein 1 Control LDimension Vista® Protein 1 Control MDimension Vista® Protein 1 Control H

Classification: Class II; Class I Product Code: JIX: JJY Panel: Clinical Chemistry (75)

3. Identification of the Legally Marketed Device:

Dimension Vista® Protein 1 Calibrator	K063663
Dimension Vista® Protein 1 Control L	K063663
Dimension Vista® Protein 1 Control M	K063663
Dimension Vista® Protein 1 Control H	K063663

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4. Device Descriptions:

Dimension Vista® Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a - acid glycoprotein immunoglobulin G a - antitrypsin immunogiobulin G Subclass 1 B »- microalobulin immunoglobulin G Subclass 2 C3 complement immunoglobulin G Subclass 3 C4 complement immunoglobulin G Subclass 4 ceruloplasmin immunoqlobulin M haptoglobin prealbumin hemopexin retinol binding protein homocysteine soluble transferrin receptor immunoglobulin A transferrin immunoglobulin E

Dimension Vista® Protein 1 Control L

Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing :

a-acid glycoprotein a 1-antitrypsin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoqlobulin G immunoglobulin G Subclass 1 immunoglobulin G Subclass 2 immunoqlobulin G Subclass 3 immunoglobulin G Subclass 4 immunoglobulin M prealbumin retinol binding protein soluble transferrin receptor transferrin

Dimension Vista® Protein 1 Control M and H

Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing :

a1-acid glycoprotein a-antitrypsin B2-microglobulin C3 complement C4 complement ceruloplasmin haptoqlobin hemopexin homocysteine immunoglobulin A immunoglobulin E
immunoglobulin G immunoqlobulin 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

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1
and Dimension Vista™ Protein 1 Control 510(k) Notification

5. Device Intended Uses:

Dimension Vista® Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista System for:

a - 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)

Immunoqlobulin G (IGG) Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoqlobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) lmmunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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® System in the quantitative determination of:

a - Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) Immunoqlobulin 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)

Dimension Vista® Protein 1 Control M and H

PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:

a1-Acid Glycoprotein (A1AG) a1-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) Immunoglobulin G Subclass 1 (IGG1) İmmunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoqlobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF)

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Dade Behring Inc. Dimension Vista™ Protein 1 Calibrator 1 and Dimension Vista™ Protein 1 Control 510(k) Notification

Medical device to which equivalence is claimed and comparison information: 6.

The Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L, M and H modified to include hemopexin (HPX), immunoglobulin G subclass 1 (IGG1), immunoglobulin G subclass 2 (IGG2), immunoqlobulin G subclass 3 (IGG3), immunoglobulin G subclass 4 (IGG4), and retinol binding protein (RBP) are substantially
equivalent in intended use to the current Dimension Vista Protein (RBP) are substantia Dimension Vista® Protein 1 Control L, M and H (K063663). The modified Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H like the current products are intended to be used for the calibration of human protein assays and for use as assayed intralaboratory quality controls respectively, on the Dimension® Vista System.

7. Conclusion

The modified Dimension Vista® Protein 1 Calibrator and Dimension Vista® Protein 1 Control L., M and H, are substantially equivalent to the legally marketed devices based on the information described above.

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Image /page/4/Picture/13 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted with four curved lines that resemble wings or stylized snakes, and the text is in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dade Behring, Inc. c/o Ms AnnaMarie Kathleen Ennis Regulatory Affairs and Compliance Specialist Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

SEP 1 1 2007

Re: K071980

Trade/Device Name: Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control H Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control L Regulation Number: 21 CFR 862.1150

Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: July 18, 2007 Received: July 18, 2007

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 with all the Act's requirements, including, but not limited to: registration and listing (21

{5}------------------------------------------------

Page 2 -

CFR Part 807); labeling (21 CFR Part 801); 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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 vours,

Robert L. Beckerf

Robert L. Becker, Jr., M.D., 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

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Indications Statement

Device Name: Dimension Vista Protein 1 Calibrator

Indications for Use: Ko 1990

Dimension Vista® Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista" System for:

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) Bo-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) Transferrin (TRF)

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 Char

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K07/1890

{7}------------------------------------------------

Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification

Indications Statement

Device Name: Dimension Vista Protein 1 Control L

Indications for Use:

011980

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® System in the quantitative determination of

a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE)

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)

Mana M Chan
Division Sign-Off

Office of In Vitro Diagnostics

Device Evaluation and Safety

51000 0 71980

{8}------------------------------------------------

Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification

Indications Statement

Device Name: Dimension Vista® Protein 1 Control M

Indications for Use:

Image /page/8/Picture/4 description: The image contains a sequence of handwritten characters and numbers. The sequence starts with the letters 'K' and 'o', followed by the number '7'. After that, the numbers '1980' are written. The handwriting appears to be somewhat rough or stylized.

Dimension Vista® Protein 1 Control M

PROT1 CON M is an assayed, mid-level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of:

a1-Acid Glycoprotein (A1AG) a3-Antitrypsin (A1AT) Bo-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) Immunoqlobulin G Subclass 3 (IGG3) Immunogiobulin 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 (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 In Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko7/980

{9}------------------------------------------------

Dade Behring Inc. Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M, H 510(k) Notification

Indications Statement

Device Name: Dimension Vista® Protein 1 Control H

Indications for Use:

Dimension Vista® Protein 1 Control H

PROT1 CON H is an assaved, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of

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) Immunoqlobulin E (IGE)

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 Char

Division Sign-Off

In Vitro Dicto רות האחרא וונ

510(k) Ko71980

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.