(47 days)
The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
Here's the analysis of the provided text regarding the ADVIA® Chemistry Microalbumin Controls:
Acceptance Criteria and Study for ADVIA® Chemistry Microalbumin Controls
This device is a Quality Control Material, and the "acceptance criteria" and "study" are focused on its stability and performance as a control, establishing substantial equivalence to a predicate device rather than a clinical efficacy study typically seen for diagnostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (quality control material), the "acceptance criteria" revolve around its stability and intended function, demonstrating it performs as expected for quality control. The provided information focuses on aspects related to its stability and composition compared to a predicate.
| Feature | Acceptance Criteria (Implied / Predicate) | Reported Device Performance (ADVIA® Chemistry Microalbumin Controls) |
|---|---|---|
| Stability (Shelf-life) | Reconstituted urine controls stable for 8 hours at 25°C, 5 days at 4°C, or 14 days at -20°C (Predicate) | Reconstituted, capped, and stored at 2-8°C stable for 28 days |
| Shelf Life (Unreconstituted) | Not explicitly stated for predicate in this context | 24 month shelf life |
| Constituent Analytes | Multiple analytes (Predicate) | Microalbumin values only (This is a differentiating feature, not a failure to meet criteria) |
| Format | Lyophilized mixture of human urine base with added constituents (Predicate) | Same (Lyophilized mixture of human urine base with added constituents) |
| Levels | Two levels (Predicate) | Same (Two levels) |
| Overall Performance | Similar to other products in commercial distribution intended for similar use (Predicate implication) | The performance of the control is similar to other products in commercial distribution intended for similar use. Values validated according to established procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the traditional sense of a patient cohort. For this quality control material, the "test" primarily refers to stability studies. The actual number of control vials or batches tested for stability is not provided.
- Data Provenance: The stability validation was performed at the manufacturing site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK. The data is retrospective in the sense that the studies were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable and not provided. For a quality control material, "ground truth" is established by laboratory analytical methods to determine its stated values and stability characteristics, not by expert consensus on clinical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used in studies where human readers interpret data (e.g., images) and their interpretations need to be reconciled for ground truth. This is not relevant for a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is used for diagnostic algorithms or imaging devices to assess how AI impacts human reader performance, which is not relevant for a quality control material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
No, a standalone (algorithm-only) study was not performed. The device itself is a physical quality control material, not a software algorithm. Its "performance" is its inherent stability and stated values, validated through laboratory procedures.
7. The Type of Ground Truth Used
The "ground truth" for the ADVIA® Chemistry Microalbumin Controls is established through laboratory analytical testing (e.g., using a reference method or validated assays) to determine the concentration of microalbumin and to confirm the stability of these concentrations over time and under various storage conditions. This is considered a form of analytical truth.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reason as point 8.
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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® ChemistryMicroalbumin Controls | 02185464 |
- e) Contract Manufacturing Site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK
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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® ChemistryMicroalbumin Control |
|---|---|---|
| Format | Lyophilized mixture of humanurine base to whichappropriate constituents havebeen added to achievespecific concentrations. | Same |
| Constituent Analytes | • Multiple analytes | • Microalbumin valuesonly |
| Stability | • Reconstituted urinecontrols are stable for 8hours at 25°C and 5 daysat 4°C if kept capped inoriginal container and freefrom contamination or 14days at -20°C. | • Reconstituted, cappedand stored at 2-8°Cstable 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
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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
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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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§ 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.