(49 days)
CLINITEK® Microalbumin Reagent Strips, Micral-Test® strips
Not Found
No
The device description explicitly states that the strips are "read" visually by comparing the color to a color chart. There is no mention of any computational analysis, image processing, or AI/ML terms.
No
The device is a diagnostic tool used for screening urine specimens to detect microalbuminuria, which aids in identifying patients at risk for kidney damage. It does not provide treatment.
Yes
The device is used for screening urine specimens for microalbuminuria "as an aid in the detection of patients at risk for developing kidney damage," which is a diagnostic purpose.
No
The device is a physical reagent strip used for testing urine, requiring visual comparison to a color chart. It is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage." This clearly indicates the device is used to examine specimens derived from the human body (urine) to provide information for diagnostic purposes (aiding in the detection of patients at risk).
- Device Description: The description details how the device is used to test for specific substances (microalbumin and creatinine) in urine specimens.
- Anatomical Site: The anatomical site is listed as "Urine," which is a human specimen.
- Intended User / Care Setting: The intended user is "professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals," which are typical settings where IVDs are used.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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 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.
Product codes (comma separated list FDA assigned to the subject device)
75 CJG, 75 JFY, JIR, JFY
Device Description
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.
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.
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
professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.
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 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.
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.
CLINITEK® Microalbumin Reagent Strips, Micral-Test® strips
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
§ 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.
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AUG 1 2 1998
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{
KG8219
Page 1 of 2
| 510(k) SAFETY AND EFFECTIVENESS SUMMARY | |
|---|---|
| Prepared: | June 23, 1998 |
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P.O. Box 70 |
| Elkhart, IN 46515 | |
| (219) 262-6929 | |
| Contact: | Rosanne M. Savol, R.A.C. |
| Manager, Regulatory Affairs | |
| Device: | Trade/Proprietary Name: MICROALBUSTIX™ Reagent Strips |
| Common/Usual Name: Test for albumin in urine | |
| Test for creatinine in urine | |
| Document Control Number: | K98 |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code | 75 CJG (Urinary Albumin, dye binding) |
| 75 JFY (Creatinine, enzymatic) | |
| Predicate Devices: | CLINITEK® Microalbumin Reagent Strips |
| Manufactured by Bayer Corporation | |
| Micral-Test® strips (Roche/Boehringer Mannheim Corporation) | |
| Device Description: | 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. | |
| Intended Use: | 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. |
1
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.
2
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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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/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
4
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)
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P. Bernhardt (for A. Montgomery)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number