(49 days)
MICROALBUSTIX Reagent Strips are for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. MICROALBUSTIX Reagent Strips are for professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.
MICROALBUSTIX Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips are dipped into a urine specimen and "read" visually by comparing the color of the strip to a color chart on the label. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute.
The MICROALBUSTIX™ Reagent Strips were studied to assess their performance in clinical settings. The studies aimed to demonstrate that typical users in decentralized point-of-care laboratories could obtain clinical test results substantially equivalent to currently used tests for microalbumin and creatinine in urine.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy in a tabular format. Instead, it describes the expected performance and concludes "substantial equivalence."
| Criterion Type | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Albumin Detection | Detection of urinary albumin at 20 to 40 mg/L | Studied in clinical settings, compared to currently used tests. |
| Creatinine Detection | Detection of creatinine. | Studied in clinical settings, compared to currently used tests. |
| Albumin-to-Creatinine Ratio | Ratio of 30 to 300 mg/g. | Studied in clinical settings, compared to currently used tests. |
| User Performance | Typical users in decentralized, point-of-care laboratories can obtain clinical test results. | Demonstrated that typical users can obtain results "substantially equivalent to current methods." |
| Comparability | Results comparable to other test methods in current clinical laboratory practice. | Studies show results "comparable to other test methods." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size (number of patients or urine specimens) used for the clinical performance studies.
- Data Provenance: The studies were conducted in "clinical settings by typical users of the system," indicating real-world or simulated real-world usage. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting the studies were likely conducted in the U.S. There is no explicit mention of whether the data was retrospective or prospective, but the phrase "studied in clinical settings" suggests a prospective collection of data for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide details on the number of experts used or their specific qualifications for establishing ground truth. The comparison was made against "currently used tests for microalbumin and creatinine in urine," implying that these established methods served as the reference standard (ground truth).
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not describe any adjudication method used for the test set. The comparison was directly against "currently used tests."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document describes studies where "typical users" read the strips and their results were compared to established methods. However, it does not explicitly state that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed in the context of comparing human readers with and without AI assistance. The device is a visual dip-and-read strip with no explicit AI component mentioned. Therefore, there's no reported effect size of how much human readers improve with AI vs. without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
The device is described as a "dip-and-read reagent strip" where results are "read visually by comparing the color of the strip to a color chart on the label." This indicates that human interpretation is integral to its operation. There is no mention of an "algorithm only without human-in-the-loop performance" as the technology relies on visual comparison by a human user.
7. Type of Ground Truth Used
The ground truth was established by "currently used tests for microalbumin and creatinine in urine." This suggests that established laboratory methods or predicate devices served as the reference standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or its sample size. The performance assessment describes "studies... in clinical settings by typical users" comparing to existing methods, implying a validation or test set rather than a distinct training set in the context of machine learning. Since this is a colorimetric strip read by eye, there isn't typically a machine learning "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of machine learning, this question is not applicable. For the development and verification of the device's colorimetric reactions and scales (which might be analogous to "training" in a broader sense), the ground truth for establishing the color chart would have been based on known concentrations of albumin and creatinine, but the document does not specify this process.
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AUG 1 2 1998
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KG8219
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| 510(k) SAFETY AND EFFECTIVENESS SUMMARY | |
|---|---|
| Prepared: | June 23, 1998 |
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P.O. Box 70Elkhart, IN 46515(219) 262-6929 |
| Contact: | Rosanne M. Savol, R.A.C.Manager, Regulatory Affairs |
| Device: | Trade/Proprietary Name: MICROALBUSTIX™ Reagent StripsCommon/Usual Name: Test for albumin in urineTest for creatinine in urine |
| Document Control Number: | K98 |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and Toxicology |
| Classification Code | 75 CJG (Urinary Albumin, dye binding)75 JFY (Creatinine, enzymatic) |
| Predicate Devices: | CLINITEK® Microalbumin Reagent StripsManufactured by Bayer CorporationMicral-Test® strips (Roche/Boehringer Mannheim Corporation) |
| Device Description: | MICROALBUSTIX Reagent Strips are firm plastic strips that contain tworeagent areas to test for microalbumin (low concentration of albumin) andcreatinine in urine. MICROALBUSTIX Reagent Strips are dipped into aurine specimen and "read" visually by comparing the color of the strip to acolor chart on the label. In addition to providing an albumin and a creatinineresult, an albumin-to-creatinine ratio can also be determined. Semi-quantitative results are available within one minute. |
| Intended Use: | MICROALBUSTIX Reagent Strips are for screening urine specimens formicroalbuminuria as an aid in the detection of patients at risk for developingkidney damage. MICROALBUSTIX Reagent Strips are for professional usein point-of-care testing locations such as physician office laboratories, clinics,and hospitals. |
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Technological Characteristics:
MICROALBUSTIX Reagent Strips are dip-and-read reagent strips to detection urinary albumin at 20 to 40 mg/L, and the albumin-to-creatinine ratio of 30 to 300 mg/g. The albumin test is based on dye binding using a high affinity sulfonephthalein dye. At a constant pH, the development of a blue color is due to the presence of albumin. The creatinine test is based on the peroxidase-like activity of a copper creatinine complex that catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3 ',5 '-tetramethylbenzidine. The color of the reagent areas are read visually by comparing to a color chart on the label. The albumin-tocreatinine ratio is determined according to a table in the package insert.
Assessment of Performance:
The performance of MICROALBUSTIX Reagent Strips was studied in clinical settings by typical users of the system and results compared to currently used tests for microalbumin and creatinine in urine. The studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods.
Conclusion:
MICROALBUSTIX Reagent Strips provide a convenient method for screening for microalbumin and creatinine in urine. Studies show that the system can be used in decentralized and point-of-care laboratories and provide clinical results comparable to other test methods in current clinical laboratory practice.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 2 1998
Rosanne Savol, R.A.C. Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46515-0070
K982219 Re : MICROALBUSTIX™ Reagent Strips Regulatory Class: I & II Product Code: JIR, JFY Dated: June 23, 1998 Received: June 24, 1998
Dear Ms. Savol:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact. the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name:
MICROALBUSTIX™ Reagent Strips
Indications for Use: MICROALBUSTIX Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria), creatinine in urine, and also determine the albumin-tocreatinine ratio in urine. The strips are read visually by comparing the color of the reacted strip to the color chart on the bottle label. MICROALBUSTIX Reagent Strips provide semi-quantitative results and can be used for screening urine specimens for microalbuminuria as an aid in the detection of persons at risk for developing kidney damage. MICROALBUSTIX Reagent Strips are for professional use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Page 8
P. Bernhardt (for A. Montgomery)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
§ 862.1645 Urinary protein or albumin (nonquantitative) test system.
(a)
Identification. A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.