(50 days)
Micral-Test® strips (Boehringer Mannheim Corporation); Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.); SPQIITMReagent(INCSTARCorp.)/Roche COBAS-FARA® II Analyzer/Ciba-Corning Express Plus; Microprotein Reagent (Sigma Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical System/DuPont XL System; Quantimetrics BGR Total Protein (Quantimetrics)/TECHNICON RA® 1000 Random Access Analyzer; CX3 Creatinine Reagent (Beckman)/ Beckman CX3 SYNCHRON® Analyzer; Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax Analytical System; Miles Creatinine Reagent (Bayer)/TECHNICON RA 1000 Random Access Analyzer; Dade® Creatinine Reagent/DuPont XL System; DCA 2000+ Microalbumin/Creatinine Assay (Bayer)
Not Found
No
The description focuses on reagent strips and instrumental reading for chemical analysis, with no mention of AI/ML or related concepts.
No.
This device is an in vitro diagnostic (IVD) test that screens for microalbuminuria, which aids in detecting patients at risk for developing kidney damage. It provides diagnostic information rather than directly treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the strips are used "as an aid in the detection of patients at risk for developing kidney damage," which clearly indicates a diagnostic purpose. The device tests for "small amounts of albumin in urine (microalbuminuria)" and "creatinine" to provide "semi-quantitative results" that are relevant for a medical diagnosis.
No
The device is described as firm plastic strips with reagent areas, which are physical components. It also requires instrumental reading by a separate hardware analyzer. This clearly indicates it is 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 strips are used to test for substances (albumin and creatinine) in a biological specimen (urine) to aid in the detection of patients at risk for developing kidney damage. This is a diagnostic purpose performed in vitro (outside the body).
- Device Description: The description confirms that the strips are used to analyze a urine specimen.
- Professional Use: The intended user is a professional in a healthcare setting, which is typical for IVDs.
- Performance Studies: The performance studies compare the results to "currently used tests for microalbumin and creatinine in urine," which are also IVD tests.
- Predicate Devices: The listed predicate devices are all IVD tests for microalbumin and creatinine.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLINITEK® Microalbumin Reagent Strips are for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.
CLINITEK Microalbumin 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 instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use.
Product codes (comma separated list FDA assigned to the subject device)
CJG, JFY
Device Description
CLINITEK® Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. CLINITEK Microalbumin Reagent Strips are dipped into a urine specimen and "read" instrumentally by the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio is also determined. Semi-quantitative results are available within one minute.
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 CLINITEK® Microalbumin 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.
Micral-Test® strips (Boehringer Mannheim Corporation); Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.); SPQIITMReagent(INCSTARCorp.)/Roche COBAS-FARA® II Analyzer/Ciba-Corning Express Plus; Microprotein Reagent (Sigma Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical System/DuPont XL System; Quantimetrics BGR Total Protein (Quantimetrics)/TECHNICON RA® 1000 Random Access Analyzer; CX3 Creatinine Reagent (Beckman)/ Beckman CX3 SYNCHRON® Analyzer; Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax Analytical System; Miles Creatinine Reagent (Bayer)/TECHNICON RA 1000 Random Access Analyzer; Dade® Creatinine Reagent/DuPont XL System; DCA 2000+ Microalbumin/Creatinine Assay (Bayer)
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
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
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SEP - 9 1991
Page 1 of 2
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | July 17, 1997 |
|---|---|
| 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: CLINITEK® Microalbumin Reagent Strips |
| Common/Usual Name: Test for microalbumin in urine | |
| Test for creatinine in urine | |
| Document Control Number: K97 | |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 JIR (Urinary Protein or Albumin) | |
| 75 CGX (Alkaline Picrate, Colorimetry, | |
| Creatinine) | |
| Predicate Devices: | Micral-Test® strips (Boehringer Mannheim Corporation); Microalbumin |
| Assay/Array® Analyzer (Beckman Instruments Inc.); | |
| SPQIITMReagent(INCSTARCorp.)/Roche COBAS-FARA® II | |
| Analyzer/Ciba-Corning Express Plus; Microprotein Reagent (Sigma | |
| Diagnostics)/Roche COBAS MIRA Analyzer/Paramax® Analytical | |
| System/DuPont XL System; Quantimetrics BGR Total Protein | |
| (Quantimetrics)/TECHNICON RA® 1000 Random Access Analyzer; | |
| CX3 Creatinine Reagent (Beckman)/ Beckman CX3 SYNCHRON® | |
| Analyzer; Paramax® Creatinine Reagent (Dade Diagnostics)/Paramax | |
| Analytical System; Miles Creatinine Reagent (Bayer)/TECHNICON | |
| RA 1000 Random Access Analyzer; Dade® Creatinine | |
| Reagent/DuPont XL System; DCA 2000+ Microalbumin/Creatinine | |
| Assay (Bayer) |
1
Device Description:
CLINITEK® Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. CLINITEK Microalbumin Reagent Strips are dipped into a urine specimen and "read" instrumentally by the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio is also determined. Semi-quantitative results are available within one minute.
Intended Use:
CLINITEK® Microalbumin Reagent Strips are for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use in point-of-care testing locations such as physician office laboratories, clinics, and hospitals.
Technological Characteristics:
The CLINITEK® Microalbumin assay is a dip-and-read reagent strip allowing detection of 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 by the CLINITEK® 50 and CLINITEK® 100 instrument at specified times and the results are displayed or printed in clinically meaningful units.
Assessment of Performance:
The performance of CLINITEK® Microalbumin 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:
CLINITEK® Microalbumin Reagent Strips for use with the CLINITEK® 50 and CLINITEK® 100 Urine Chemistry Analyzers 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 is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP - 9 1997
Rosanne M. Savol, R.A.C. . Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46514-0070
Re : K972706 CLINITEK® Microalbumin Reagent Strips Regulatory Class: II Product Code: CJG, JFY Dated: July 17, 1997 Received: July 21, 1997
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 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. Existinq major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 requlations.
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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 ene regaration Choroin" (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 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):
Device Name:
Indications for Use:
CLINITEK® Microalbumin Reagent Strips
CLINITEK Microalbumin 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 instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin 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) | ||
|---|---|---|
| Division of Clinical Laboratory Devices 510(k) Number: K972726 | ||
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) | ||
| Page® |