(207 days)
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No
The device description explicitly states that the strips are "read visually by comparing the color of the reacted strip to the color chart on the bottle label," indicating a manual, non-AI/ML based interpretation method. There are no mentions of AI, ML, or related technologies in the provided text.
No
This device is a diagnostic tool designed to test for small amounts of albumin and creatinine in urine, providing semiquantitative results. It does not provide any treatment or therapy.
No
The device provides semiquantitative results for substances in urine to identify individuals at risk for developing kidney disease, which is a screening or monitoring function rather than a definitive diagnosis.
No
The device is a physical reagent strip that is read visually, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to test for small amounts of albumin and creatinine in urine, and to determine the albumin-to-creatinine ratio in urine. This is a diagnostic test performed on a biological sample (urine) outside of the body.
- Device Description: The description further clarifies that the device is a reagent strip that is dipped into a urine specimen and read visually to obtain results. This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The summary of performance studies mentions comparing the results obtained with the device to "currently used laboratory tests for microalbumin and creatinine in urine." This comparison to established laboratory diagnostic methods further supports its classification as an IVD.
- Predicate Device: The predicate device listed is also a "Reagent Strip" for testing microalbumin, which is a common type of IVD.
Therefore, based on the provided information, the MICROALBUSTIX Reagent Strips (OTC) are an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MICROALBUSTIX Reagent Strips (OTC) are intended for home use by testing persons at risk for developing kidney damage
MICROALBUSTIX Reagent Strips (OTC) 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-to-creatinine 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 (OTC) provide semiquantitative results and are intended for home use by persons at risk of developing kidney disease.
Product codes (comma separated list FDA assigned to the subject device)
75 JIR, 75 JFY
Device Description
MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips (OTC) 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use by testing persons at risk for developing kidney damage
home use by persons at risk of developing kidney disease.
Description of the training set, sample size, data source, and annotation protocol
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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 performance of MICROALBUSTIX Reagent Strips (OTC) was studied in clinical and home use settings by typical lay users and results compared to currently used laboratory tests for microalbumin and creatinine in urine. The studies demonstrated that lay users can obtain clinical test results that are substantially equivalent to current methods.
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.
MICROALBUSTIX™ Reagent Strips (Professional)
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).
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§ 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.
0
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510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | April 15, 1999 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P.O. Box 70 |
| Elkhart, IN 46515 | |
| (219) 262-6928 | |
| Contact: | George M. Tancos, R.A.C. |
| Manager, Regulatory Compliance | |
| Device: | Trade/Proprietary Name: MICROALBUSTIX™ Reagent Strips (OTC) |
| Common/Usual Name: Test for albumin in urine | |
| Test for creatinine in urine | |
| Document Control Number: K99 1315 | |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code: 75 JIR [Protein or Albumin (Urinary, Non- | |
| Quantitative)] | |
| 75 JFY (Creatinine, enzymatic) | |
| Predicate Devices: | MICROALBUSTIX™ Reagent Strips (Professional) |
| Manufactured by Bayer Corporation | |
| Device Description: | MICROALBUSTIX Reagent Strips (OTC) are firm plastic strips that |
| contain two reagent areas to test for microalbumin (low concentration of | |
| albumin) and creatinine in urine. MICROALBUSTIX Reagent Strips | |
| (OTC) 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. | |
| Intended Use: | MICROALBUSTIX Reagent Strips (OTC) are intended for home use by |
| testing persons at risk for developing kidney damage |
1
Bayer Corporation, Business Group Diagnostics MICROALBUSTIX™ Reagent Strips (OTC) S&E Summary Page 2 of 2
Technological Characteristics:
MICROALBUSTIX Reagent Strips (OTC) 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',5,5'-tetramethylbenzidine. The color of the reagent areas are read visually by comparing to a color chart on the label. The albumin-to-creatinine ratio is determined according to a table in the package insert.
Assessment of Performance:
The performance of MICROALBUSTIX Reagent Strips (OTC) was studied in clinical and home use settings by typical lay users and results compared to currently used laboratory tests for microalbumin and creatinine in urine. The studies demonstrated that lay users can obtain clinical test results that are substantially equivalent to current methods.
Conclusion:
MICROALBUSTIX Reagent Strips (OTC) provide a convenient method for testing for microalbumin and creatinine in urine. Studies show that the product can be used by lay persons to obtain results comparable to results obtained by health care professionals.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Nov 1 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. George M. Tancos Manager, Regulatory Compliance Bayer Corporation Business Group Diagnostics 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46515-0070
Re: K991315
Trade Name: MICROALBUSTIX™ Reagent Strips (OTC) Regulatory Class: II Product Code: JFY Regulatory Class: I Product Code: JIR Dated: August 2, 1999 Received: August 3, 1999
Dear Mr. Tancos:
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 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). 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 (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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Page 2
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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
4
510(k) Number (if known): K991315
Device Name:
MICROALBUSTIXTM Reagent Strips (OTC)
Indications for Use:
MICROALBUSTIX Reagent Strips (OTC) 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-to-creatinine 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 (OTC) provide semiquantitative results and are intended for home use by persons at risk of developing kidney disease.
Lisa Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number .
(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)