(48 days)
Not Found
No
The document describes calibrators and controls for in vitro diagnostic tests on a specific system. There is no mention of AI or ML in the intended use, device description, or any other section. The focus is on the chemical composition and intended use for quality control.
No
These products are described as in vitro diagnostic products for calibration and quality control, used for assessing precision and analytical bias of a system, not for treating or preventing disease.
No
This device is described as an "in vitro diagnostic product for the calibration" and an "assayed intralaboratory quality control." Its purpose is to calibrate and assess the precision and analytical bias of instruments, not to directly diagnose a medical condition in a patient.
No
The device description clearly states that the products are "lyophilized, polygeline based product containing urinary a1-microglobulin, cystatin C and serum albumin of human origin" and "liquid human serum based products containing..." These are physical substances, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that these products are "in vitro diagnostic product" and "assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of..." various analytes on the Dimension Vista® System. This clearly indicates their use in testing samples taken from the human body (in vitro) to provide information for medical purposes (diagnostic).
N/A
Intended Use / Indications for Use
Dimension Vista® Protein 3 Calibrator
PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the q-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods.
- For serum, plasma and cerebrospinal fluid
Dimension Vista® Protein 3 Control
PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a-Microglobulin (A1MIC), specialty Albumin (SALB) and Microalbumin (MALB) on the Dimension Vista® System.
1 For cerebrospinal fluid (CSF)
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)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
specialty Albumin* (sALB)
soluble Transferrin Receptor (STFR)
Transferrin (TRF)
*For serum and plasma
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:
- a Acid Glycoprotein (A1AG)
a 1-Antitrypsin (A1AT)
B2- Microglobulin (B2MIC)
C3 Complement (C3)
C4 Complement (C4)
Ceruloplasmin (CER)
Haptoglobin (HAPT)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
specialty Albumin* (sALB)
soluble Transferrin Receptor (STFR)
Transferrin (TRF)
*For serum and plasma
Dimension Vista® Protein 1 Control H
PROT1 CON H is an assayed, 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)
a1-Antitrypsin (A1AT)
B2- Microglobulin (B2MIC)
C3 Complement (C3)
C4 Complement (C4)
Ceruloplasmin (CER)
Haptoglobin (HAPT)
Homocysteine (HCYS)
Immunoglobulin A (IGA)
Immunoglobulin E (IGE)
Immunoglobulin G (IGG)
Immunoglobulin M (IGM)
Prealbumin (PREALB)
specialty Albumin* (sALB)
soluble Transferrin Receptor (STFR)
Transferrin (TRF)
*For serum and plasma
Product codes (comma separated list FDA assigned to the subject device)
JIX, JJY
Device Description
Dimension Vista® Protein 3 Calibrator
PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary a1-microglobulin, cystatin C and serum albumin of human origin.
Dimension Vista® Protein 3 Control
PROT3 CON is a multi-analyte, low level lyophilized, polygeline and rabbit albumin based product containing urinary a1 -microglobulin and serum albumin of human origin.
Dimension Vista® Protein 1 Control L
Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing:
- α1-acid glycoprotein
αι-antitrypsin
C3 complement
C4 complement
ceruloplasmin
haptoglobin
homocysteine
immunoglobulin A
immunoglobulin E
immunoglobulin G
immunoglobulin M
prealbumin
soluble transferrin receptor
albumin
transferrin
Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H
Protein I Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing:
| α₁-acid glycoprotein | immunoglobulin A |
|---|---|
| α₁-antitrypsin | immunoglobulin E |
| ß₂-microglobulin | immunoglobulin G |
| C3 complement | immunoglobulin M |
| C4 complement | prealbumin |
| ceruloplasmin | soluble transferrin receptor |
| haptoglobin | albumin |
| homocysteine | 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 § 862.9.
0
Dade Behring
Every minute of every day™
0CT 1 7 2007
510(k) Summary for Dimension Vista® Protein 3 Calibrator
Dimension Vista® Protein 3 Control Dimension Vista® Protein 1 Control L Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control 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: KO72435
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| | Manufacturer: | Dade Behring Inc. Marburg GmbH
Emil-von-Behring Str. 76
35041 Marburg, Germany |
|----|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Information: | Dade Behring Inc.
P.O. Box 6101
Newark, Delaware 19714-6101
Attn: A. Kathleen Ennis
Tel: 302-631-9352
Fax: 302-631-6299 |
| | Preparation date: | August 27, 2007 |
| 2. | Device Name: | Dimension Vista® Protein 3 Calibrator
Dimension Vista® Protein 3 Control
Dimension Vista® Protein 1 Control L
Dimension Vista® Protein 1 Control M
Dimension Vista® Protein 1 Control H |
| | Classification:
Product Code:
Panel: | Class II; Class I
JIX; JJY
Clinical Chemistry (75) |
Identification of the Legally Marketed Device: 3.
| Dimension Vista® Protein 3 Calibrator | K063508 |
|---|---|
| Dimension Vista® Protein 3 Control | K063508 |
| Dimension Vista® Protein 1 Control L | K063663 |
1
DADE BEHRING
Every minute of every day"
Dimension Vista® Protein 1 Control M K063663 Dimension Vista® Protein 1 Control H K063663
Device Descriptions:
Dimension Vista® Protein 3 Calibrator
PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary a1-microglobulin, cystatin C and serum albumin of human origin.
Dimension Vista® Protein 3 Control
PROT3 CON is a multi-analyte, low level lyophilized, polygeline and rabbit albumin based product containing urinary a1 -microglobulin and serum albumin of human origin.
Dimension Vista® Protein 1 Control L
Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing:
- α1-acid glycoprotein αι-antitrypsin C3 complement C4 complement ceruloplasmin haptoglobin homocysteine immunoglobulin A
immunoglobulin E immunoglobulin G immunoglobulin M prealbumin soluble transferrin receptor albumin transferrin
Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H
Protein I Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing:
| α₁-acid glycoprotein | immunoglobulin A |
|---|---|
| α₁-antitrypsin | immunoglobulin E |
| ß₂-microglobulin | immunoglobulin G |
| C3 complement | immunoglobulin M |
| C4 complement | prealbumin |
| ceruloplasmin | soluble transferrin receptor |
| haptoglobin | albumin |
| homocysteine | transferrin |
2
5. Device Intended Uses:
Dimension Vista® Protein 3 Calibrator
PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the a1 -Microglobulin (A1MIC), Cystatin C(CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods.
- For serum, plasma and cerebrospinal fluid
Dimension Vista® Protein 3 Control
PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a 1-Microglobulin (A IMIC), precision and thaty trear blas in the acted by on the Dimension (11777).
specialty Albumin (sAlb)** and Microalbumin (MALB) on the Dimension Vista " System.
** For cerebrospinal fluid (CSF)
Dimension Vista® Protein 1 Control L
PROTI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista 9 System in the quantitative determination of:
a1-Acid Glycoprotein (A1AG) a - Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA)
Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) soluble Transferrin Receptor (sTFR) specialty Albumin (sALB)*** Transferrin (TRF)
3
Dade Behring
Every minute of every day"
Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control 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
| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin A (IGA) |
|---|---|
| α₁-Antitrypsin (A1AT) | Immunoglobulin E (IGE) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G (IGG) |
| C3 Complement (C3) | Immunoglobulin M (IGM) |
| C4 Complement (C4) | Prealbumin (PREALB) |
| Ceruloplasmin (CER) | specialty Albumin (sALB)*** |
| Haptoglobin (HAPT) | soluble Transferrin Receptor (STFR) |
| Homocysteine (HCYS) | Transferrin (TRF) |
| *** For serum and plasma |
6. Medical device to which equivalence is claimed and comparison information:
Dimension Vista® Protein 3 Calibrator and Dimension Vista® Protein 3 Control modified to include specialty Albumin (sALB), are substantially equivalent in intended use to the current Dimension Vista® Protein 3 Calibrator and Dimension Vista® Protein 3 Control (K063508). The modified Protein 3 Calibrator and Protein 3 Control, 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.
Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H modified to include specialty Albumin (sALB), are substantially equivalent in intended use to the current Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H (K063663). Modified Protein 1 Control L, M, and H, like the current products, are intended to be used as assaved intralaboratory quality controls on the Dimension® Vista System.
7. Conclusion
The modified Dimension Vista® Protein 3 Calibrator, Dimension Vista® Protein 3 Control and Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista Protein 1 Control H, are substantially equivalent to the legally marketed devices based on the information described above.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dade Behring Inc. c\o Ms. A. Kathleen Ennis Sr. Regulatory Affairs & Compliance Spec. 500 GBC Drive, MS 514, P.O. Box 6101 Newark, DE 19714-6101
OCT 1 7 2007
K072435 Re:
Trade Name: Dimension Vista® Protein 3 Calibrator, Dimension Vista® Protein 3 Control, Dimension Vista® Protein 3 Control L, Dimension Vista® Protein 3 Control M, Dimension Vista® Protein 3 Control H Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJY Dated: August 28, 2007 Received: August 30, 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 --
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 logally 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) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications Statement
Device Name: Dimension Vista® Protein 3 Calibrator
Indications for Use:
Dimension Vista® Protein 3 Calibrator
PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the q-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods.
- For serum, plasma and cerebrospinal fluid
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)
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
072
7
Indications Statement
Device Name: Dimension Vista® Protein 3 Control
Indications for Use:
Dimension Vista® Protein 3 Control Intended Use
PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a-Microglobulin (A1MIC), specialty Albumin (SALB) and Microalbumin (MALB) on the Dimension Vista® System.
1 For cerebrospinal fluid (CSF)
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)
Page 275
Signature
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072435
8
Indications Statement
Device Name: Dimension Vista® Protein 1 Control L
Indications for Use:
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) Homocysteine (HCYS) Immunoglobulin A (IGA)
Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin* (sALB) soluble Transferrin Receptor (STFR) Transferrin (TRF)
*For serum and plasma
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)
CLL
Page 3 of 5
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072435
IVISION SIgn-O
9
Indications Statement
Device Name: Dimension Vista® Protein 1 Control M
Indications for Use:
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:
- a Acid Glycoprotein (A1AG) a 1-Antitrypsin (A1AT) B2- Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS)
Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin* (sALB) soluble Transferrin Receptor (STFR) Transferrin (TRF)
*For serum and plasma
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)
ivision Sign Off
Division Sign-Off
Page 4 of 5
Office of In Vitro Diagnostic Device Evaluation and Safety
5100(K) K072435
10
Indications Statement
Device Name: Dimension Vista® Protein 1 Control H
Indications for Use:
Dimension Vista® Protein 1 Control H
PROT1 CON H is an assayed, 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) a1-Antitrypsin (A1AT) B2- Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS)
Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin* (sALB) soluble Transferrin Receptor (STFR) Transferrin (TRF)
*For serum and plasma
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CfCL
Page 54/5
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
FO(K) K072435