(47 days)
Not Found
No
The document describes a chemical control solution for a chemistry analyzer, with no mention of AI or ML in its intended use, description, or performance studies.
No
This device is an in vitro diagnostic control for laboratory systems, not a device used to treat or therapy-deliver to a patient.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for in vitro diagnostic use."
No
The device description explicitly states it is a "human urine based solution containing various constituents," indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method."
This statement clearly indicates that the device is intended to be used outside of the body (in vitro) for diagnostic purposes, specifically for controlling the performance of a diagnostic test (Microalbumin method) on a chemistry system.
N/A
Intended Use / Indications for Use
The ADVIA® Chemistry Microalbumin Controls is intended for in vitro diagnostic use in the control of ADVIA® Chemistry systems for the Microalbumin method.
The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
Product codes (comma separated list FDA assigned to the subject device)
75 JJW, JJY
Device Description
The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The stability of the ADVIA® Chemistry Microalbumin Control values have been validated according to established procedures at the manufacturing site. The performance of the control is similar to other products in commercial distribution intended for similar use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 862.1660 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.
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OCT 3 - 2005
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® Chemistry Microalbumin Controls
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
The assigned 510(k) number is: K052242
1. Submitter's name, address and telephone number:
Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC A subsidiary of Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591 TEL: 914-524-3494 FAX: 914-524-2500 Email: andres.holle.b@bayer.com
2. Name of the device:
- a) Classification Names: Quality Control Material, §862.1660 Classification: Class I Product Code: 75 JJW
- b) Common name: Assayed Quality Control Material
- c) Proprietary name: ADVIA® Chemistry Microalbumin Controls
- d) The device:
| Product Name | Part Number |
|---|---|
| ADVIA® Chemistry | |
| Microalbumin Controls | 02185464 |
- e) Contract Manufacturing Site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK
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page 2 of 3
3. Predicate Device:
| Product Name | Part Numbers |
|---|---|
| Urine Controls | AU2352, AU2353 |
Contract Manufacturing Site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK
510(k) Number: K043266
4. Description of the device:
The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
5. Statement of Intended Use
ADVIA® Chemistry Microalbumin Controls is intended for in vitro diagnostic use in the control of ADVIA® Chemistry systems for the Microalbumin method.
6. Product Performance
The stability of the ADVIA® Chemistry Microalbumin Control values have been validated according to established procedures at the manufacturing site. The performance of the control is similar to other products in commercial distribution intended for similar use.
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7. Substantial Equivalence:
| Feature | Predicate Urine Controls
(K043266) | ADVIA® Chemistry
Microalbumin Control |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Format | Lyophilized mixture of human
urine base to which
appropriate constituents have
been added to achieve
specific concentrations. | Same |
| Constituent Analytes | • Multiple analytes | • Microalbumin values
only |
| Stability | • Reconstituted urine
controls are stable for 8
hours at 25°C and 5 days
at 4°C if kept capped in
original container and free
from contamination or 14
days at -20°C. | • Reconstituted, capped
and stored at 2-8°C
stable for 28 days
• 24 month shelf life |
| Levels | • Two levels | Same |
Andrea Halle
Andres Holle Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
8/12/2005
Date
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. 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 fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
OCT 3 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Baver HealthCare LLC 511 Benedict Avenue Tarrytown, NY 10591
Re: K052242
Trade/Device Name: ADVIA® Chemistry Microalbumin Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: August 12, 2005 Received: August 18, 2005
Dear Mr. Holle:
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,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K052242
Device Name: ADVIA® Chemistry Microalbumin Control
Indications For Use:
The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 S
Office of In Vitro Diagnostic Device Evaluation and Safety
052142
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