(68 days)
Not Found
No
The description details a standard immunochemical reaction and light scattering method for quantitative determination, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device is an in vitro diagnostic reagent and related products used for the quantitative determination of albumin in human urine, aiding in the diagnosis of kidney and intestinal disease. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MALB method is "an in vitro diagnostic reagent" and that "Measurement of albumin aids in the diagnosis of kidney and intestinal disease."
No
The device description clearly outlines physical components (reagent cartridge, calibrator, control) and a chemical reaction (immunochemical reaction) used for measurement, indicating it is not a software-only device.
Yes, all three devices described are explicitly stated to be In Vitro Diagnostic (IVD) devices in their "Intended Use / Indications for Use" sections:
- Dimension Vista™ MALB Flex® reagent cartridge: "The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine..."
- Dimension Vista™ Protein 3 Calibrator: "Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method..."
- Dimension Vista™ Protein 3 Control: "Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB)..." (While not explicitly using the phrase "in vitro diagnostic" in this specific sentence, its function as a quality control for an IVD method strongly implies it is also considered an IVD product in this context, and the previous two items confirm the overall system is for IVD use).
Furthermore, the description of the MALB Flex® reagent cartridge details an immunochemical reaction performed in vitro (outside the body) to measure a substance in a human sample (urine), which is a hallmark of an IVD. The calibrator and control are also used in vitro to ensure the accuracy of this diagnostic test.
N/A
Intended Use / Indications for Use
Dimension Vista™ MALB Flex® reagent cartridge:
The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.
Dimension Vista™ Protein 3 Calibrator:
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista " System.
Dimension Vista™ Protein 3 Control:
Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
DCF; JIX; JJY
Device Description
Dimension Vista™ MALB Flex® reagent cartridge
Proteins contained in human urine 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 albumin in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 3 Calibrator
PROT3 CAL is a lyophilized, polygeline based (with urinary proteins of human origin) product containing Albumin.
Dimension Vista™ Protein 3 Control
PROT3 CON is a lyophilized, polygeline and albumin based product containing albumin of human origin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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)
The Dimension Vista™ MALB assay was compared to the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 5.87 to 332.74 mg/L. Regression analysis of these results yielded the following equation:
y = 1.0583x - 1.2599
r = 0.9996
n = 100
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
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.
0
510(k) Summary for Dimension Vista™ MALB Flex® reagent cartridge Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
SEP 1 9 2006
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.
Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number K061990. The number is handwritten in black ink. The text is likely part of a document or form that requires the identification of a specific 510(k) number.
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbH |
|---|---|
| Emil-von-Behring Str. 76 | |
| D-35001 | |
| Marburg, Germany |
Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
Preparation date: July 11, 2006
- Dimension Vista™ Microalbumin Flex® reagent cartridge (MALB) 2. Device Name: Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
| Classification: | Class II; Class II; Class I |
|---|---|
| Product Code: | DCF; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |
3. ldentification of the Legally Marketed Device:
Dade Behring N Antiserum to Human Albumin - K860894 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control LC - K991704
1
4. Device Description:
Dimension Vista™ MALB Flex® reagent cartridge
Proteins contained in human urine 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 albumin in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 3 Calibrator
PROT3 CAL is a lyophilized, polygeline based (with urinary proteins of human origin) product containing Albumin.
Dimension Vista™ Protein 3 Control
PROT3 CON is a lyophilized, polygeline and albumin based product containing albumin of human origin.
5. Device Intended Use:
Dimension Vista 1 MALB Flex® reagent cartridge:
The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of Albumin aids in the diagnosis of kidney and intestinal disease.
Dimension Vista™ Protein 3 Calibrator:
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista " System.
Dimension Vista™ Protein 3 Control:
Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.
6. Medical device to which equivalence is claimed and comparison information:
The Dimension Vista™ MALB Flex reagent cartridge. Dimension Vista™ Protein 3 Calibrator and Dimension Vista™ Protein 3 Control are substantially equivalent to the Dade Behring N Antiserum to Human Albumin assay (K860894) assay, N Protein Standard SL (K012470) and N/T Protein Control LC (K991704), respectively. The Dimension Vista™ MALB assay, like the Dade Behring N Antiserum to Human Albumin assay is an in vitro diagnostic reagent for the quantitative measurement of Microalbumin (MALB) in human urine by means of particle enhanced immunonephelometry.
7. Device Performance Characteristics:
The Dimension Vista™ MALB assay was compared to the Dade Behring N Antiserum to Human Albumin assay on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 5.87 to 332.74 mg/L. Regression analysis of these results yielded the following equation:
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Method Comparison Study
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 9 2006
Ms. Kathleen Dray-Lyons Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714-6101
K061990 Re:
Trade/Device Name: Dimension Vista™ MALB Flex® reagent cartridge Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: DCF, JIT, JJY Dated: July 11, 2006 Received: July 13, 2006
Dear Ms. Dray-Lyons:
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).
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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health_
Enclosure
4
Dade Behring Inc. Dimension Vista™ MALB 510(k) Notification
Indications Statement
Dimension Vista™ MALB Flex® reagent cartridge Device Name: Dimension Vista™ Protein 3 Calibrator Dimension Vista™ Protein 3 Control
Indications for Use:
Dimension Vista™ MALB Flex® reagent cartridge:
The MALB method is an in vitro diagnostic reagent for the quantitative determination of albumin in human urine on the Dimension Vista™ System. Measurement of albumin aids in the diagnosis of kidney and intestinal disease.
Dimension Vista™ Protein 3 Calibrator:
Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the Microalbumin (MALB) method on the Dimension Vista™ System.
Dimension Vista™ Protein 3 Control:
Protein 3 Control is an assayed intralaboratory quality control for the assessment of precision and analytical bias in determination of Microalbumin (MALB) on the Dimension Vista™ System.
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)
CAC
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K061990
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