(63 days)
Multistix PRO™ 11 Reagent Strips, Multistix PRO™ 10LS Reagent Strips, Multistix PRO™ 7G Reagent Strips, CLINITEK® 50, CLINITEK® 100, CLINITEK® 200+, CLINITEK® 500 Urine Chemistry Analyzers
Not Found
No
The description focuses on chemical reagent strips and an automated analyzer for urine chemistry, with no mention of AI or ML technologies.
No
The device is a system of reagent strips used for diagnostic testing of urine. It is explicitly stated that the "Test results can be used along with other diagnostic information to rule out certain disease states," indicating a diagnostic rather than a therapeutic function.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is intended "to assist diagnosis" and that "Test results can be used along with other diagnostic information to rule out certain disease states." This indicates its role in aiding the diagnostic process.
No
The device description clearly states it is a "roll of firm plastic to which are affixed 490 reagent strips," which are physical components, not software. It is also used with a hardware analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in at-risk patient groups to assist diagnosis" in various areas like kidney function, carbohydrate metabolism, urinary tract infections, and liver function. It also mentions measuring physical characteristics and that "Test results can be used along with other diagnostic information to rule out certain disease states." This clearly indicates a diagnostic purpose.
- Device Description: The device is a "Reagent Pak" containing "reagent strips" with "reagent areas to test for" various substances in urine. Reagents and test strips used to analyze biological samples are characteristic components of IVDs.
- Sample Type: The device is used with a "Urine Chemistry Analyzer," indicating it analyzes a biological sample (urine).
- Care Setting and User: It's for "professional use in centralized laboratory locations such as in hospitals and reference laboratories," which are typical settings for performing in vitro diagnostic tests.
The definition of an IVD generally involves devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive 12th pad that is used for the determination of the specimen color.
The CLINITEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. The CLINITEK ATLAS PRO 12 Reagent Pak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.
Product codes (comma separated list FDA assigned to the subject device)
JFY; JIP; JIP; JIL; LJX
Device Description
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive 12th pad that is used for the determination of the specimen color.
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 centralized laboratory locations such as in hospitals and reference laboratories.
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 the CLINITEK ATLAS PRO 12 Reagent Pak System was studied internally and in clinical settings. The studies demonstrated that typical users in centralized laboratories could obtain clinical test results that are comparable to commonly used laboratory tests.
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.
Multistix PRO™ 11 Reagent Strips, Multistix PRO™ 10LS Reagent Strips, Multistix PRO™ 7G Reagent Strips, CLINITEK® 50, CLINITEK® 100, CLINITEK® 200+, CLINITEK® 500 Urine Chemistry Analyzers
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
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
'JUL
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | April 25, 2002 |
|---|---|
| Submitter: | Bayer Diagnostics |
| Address: | Bayer Diagnostics |
| 511 Benedict Ave. | |
| Tarrytown, NY 10591 | |
| phone: (914)-524-2446 | |
| Contact: | Kenneth T. Edds, Ph.D. |
| Manager, Regulatory Affairs |
| Device: | |
|---|---|
| Trade/Proprietary Name: | CLINITEK ATLAS® PRO™ 12 Reagent |
| Pak System | |
| Common/Usual Name: | Reagent Strips for Urinalysis |
| Test for Creatinine in Urine | |
| Document Control Number: | K02/428 |
| Classification: | |
|---|---|
| Name: | Creatinine test system |
| Class: | II |
| CFR: | 21 CFR §862. 1225 |
| Code: | 75 JFY |
Predicate Devices:
Multistix PRO™ 11 Reagent Strips
Multistix PRO™ 10LS Reagent Strips
Multistix PRO™ 7G Reagent Strips
CLINITEK® 50, CLINITEK® 100, CLINITEK® 200+,
CLINITEK® 500 Urine Chemistry Analyzers
Manufacturer: Bayer Diagnostics
Page 1 of 3
1
Device Description:
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive 12th pad that is used for the determination of the specimen color.
Intended Use:
The CLINITEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. The CLINITEK ATLAS PRO 12 Reagent Pak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.
Technological Characteristics:
The CLINITEK ATLAS PRO 12 Reagent Pak system includes a new "Protein Low" reagent that allows "low level" detection of urine albumin at 15 mg/dL in addition to the current protein reagent used for detection of "high level" protein at 30 mg/dL. A new creatinine reagent is used for the estimation of the protein-to-creatinine ratio of the urine specimen based on all three tests. Use of the protein-to-creatinine ratio can assist in the diagnosis of kidney function by minimizing the impact of changes in the protein result due to exercisc, orthostatic proteinuria, diuresis and urine concentration. The ratio allows for the use of single-void specimens in the discrimination of normal and abnormal levels of protein. Ratio results of >150 mg/g are considered to be abnormal.
The assay for low level protein (albumin) is based on dye binding using the high affinity dye, Bis(3',3"-diiodo-4',4"-dihydroxy-5',5"-dinitrophenyl)-3,4,5,6tetrabromosulfonephthalein). At a constant pH, the development of a blue color is owing to the presence of albumin; the intensity of the color is proportional to the albumin concentration. The assay for creatinine is based on the peroxidase-like activity of copper creatinine complexes that catalyze the reaction of diisopropylbenzene dihydroperoxide and 3,3',5,5'-tetramethyl-benzidine.
2
Assessment of Performance:
The performance of the CLINITEK ATLAS PRO 12 Reagent Pak System was studied internally and in clinical settings. The studies demonstrated that typical users in centralized laboratories could obtain clinical test results that are comparable to commonly used laboratory tests.
Conclusion:
The CLINITEK ATLAS PRO 12 Reagent Pak System has been developed for use with the CLINITEK ATLAS Automated Urine Chemistry Analyzer. New tests for the determination of low levels of albumin and urine creatinine have been added to the CLINITEK ATLAS Automated Urine Chemistry Analyzer menu to allow for a determination of the protein-to-creatinine ratio of the urine specimen. Studies show that the product provides clinical results comparable to other test methods in current clinical practice.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
5 2002 JUL
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Diagnostics 511 Benedict Avenue Tarrytown, NY 10591
K021428 Re:
Trade/Device Name: Clinitek Atlas® Pro™ 12 Reagent Pak System Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY; JIP; JIP; JIL; LJX Dated: April 25, 2002 Received: May 3, 2002
Dear Dr. Edds:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/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
5
510(k) Number (if known): K091428
Device Name:
CLINITEK ATLAS® PRO™ 12 Reagent Pak System
Indications for Use:
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-tocreatinine ratio is also determined. In addition, each strip contains a nonreactive 12" pad that is used for the determination of the specimen color.
The CLINITEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. The CLINITEK ATLAS PRO Reagent Pak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K021428 |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|