(102 days)
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No
The summary describes a visual, qualitative, and semi-quantitative test, which typically relies on color changes interpreted visually or with a simple reader, not AI/ML for analysis. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of these technologies.
No
The device is a diagnostic test for determining various substances in urine, which helps in evaluating disorders, but it does not treat or alleviate a disease or condition.
Yes
Explanation: The device is a test for determining various metabolites in urine which are useful in the evaluation of renal, urinary, and metabolic disorders, directly indicating its use for diagnosis.
No
The device description clearly states it is a "visual qualitative and semi-quantitative test" for analyzing urine metabolites. This implies the use of physical test strips or other hardware components to interact with the urine sample and produce a visual result, which is then interpreted. The summary does not mention any software component that performs the analysis or interpretation independently of a physical test.
Yes, based on the provided information, the CHEMVIEW-10™ device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a test for the determination of various metabolites in urine. Urine is a biological specimen taken from the human body.
- Purpose: The purpose of the test is to evaluate renal, urinary, and metabolic disorders. This indicates it's used for diagnostic purposes.
- Method: It's a "visual qualitative and semi-quantitative test," which is a common method for in vitro diagnostic tests.
- Device Description: The description reinforces that it's a test for substances in urine.
- Performance Studies: The performance studies involve testing urine specimens and comparing the results to a predicate device (Roche Chemstrip®), which is also an IVD.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes. The CHEMVIEW-10™ clearly fits this description.
N/A
Intended Use / Indications for Use
CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine. These metabolites are useful in the evaluation of renal, urinary and metabolic disorder. The product will be marketed to physicians' office laboratories, clinics, hospitals and reference laboratories.
Product codes
JIL, KHE
Device Description
CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine.
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
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Indicated Patient Age Range
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Intended User / Care Setting
Physicians' office laboratories, clinics, hospitals and reference laboratories.
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
Comparison studies were conducted at three reference laboratories. Fresh Urine specimens submitted to the laboratories for urinalysis as well as spiked urine specimens were tested simultaneously with the CHEMVIEW-10™ and Roche's Chemstrip® urinalysis reagent test strips. Testing data for glucose and occult blood (Class II devices) was collected. A total of 188 specimens were tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison studies; 188 specimens; Glucose test results showed 99.5% agreement within the same color block and 100% agreement within one color block. Occult blood test results showed 86.7% agreement within the same color block and 97.34% agreement within one color block.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Glucose: 99.5% agreement within the same color block and 100% agreement within one color block.
- Occult blood: 86.7% agreement within the same color block and 97.34% agreement within one color block.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.
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CENOGENICS CORPORATION 100 ROUTE 520 MORGANVILLE, NJ 07751 (732) 536-6457 (732) 972-8527 fax inquiry@cenogenics.com
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
CHEMVIEW-10 ™ Urinalysis Test Strips for urobilinogen, glucose, Proprietary name: ketones, bilirubin, protein, nitrite, pH, occult blood, specific gravity and leukocytes.
Common name: Reagent test strip for urinalysis.
Classification: 21CFR 2900, Class I
Classification number: 75KQO
- Establishment: Cenogenics Corporation 100 Route 520 Morganville, New Jersey 07751
Contact: Nitza Katz Vice President
CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine.
Comparison studies were conducted at three reference laboratories. Fresh Urine specimens submitted to the laboratories for urinalysis as well as spiked urine specimens were tested simultaneously with the CHEMVIEW-10™ and Roche's Chemstrip® urinalysis reagent test strips. Testing data for glucose and occult blood (Class II devices) was collected. A total of 188 specimens were tested. Glucose test results showed 99.5% agreement within the same color block and 100% agreement within one color block. Occult blood test results showed 86.7% agreement within the same color block and 97.34% agreement within one color block.
The CHEMVIEW-10™ is substantially equivalent to the Roche Chemstrip® in both test principle and clinical performance:
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- Both devices are visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine.
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- In a comparison study of 188 urine specimens for the two Class II analytes, the in a companion clauy of 100 annual the Chemstrip® was demonstrated to be:
- a. 99.5% for glucose and
- b. 94.2 for occult blood.
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- Both products are similar in sensitivity:
| DETECTION RANGE | ||
|---|---|---|
| ANALYTE | CHEMVIEW™ | CHEMSTRIP® |
| UROBILINOGEN | 1 to 12 mg/dl | 1 to 12 mg/dl |
| GLUCOSE | 100 to 1000 mg/dl | 50 to 1000 mg/dl |
| KETONES | 5 mg (+/-) to 80 mg/dl (+++) | + (small) to +++ (large) |
| BILIRUBIN | 0.5 mg/dl to 3 mg/dl | 0.5 mg/dl |
| PROTEIN | 30 to 1000 mg/dl | 30 - 500 mg/dl |
| NITRITE | 0.05 mg/dl | 0.05 mg/dl |
| pH | 5 to 9 | 5 to 9 |
| OCCULT BLOOD | 0.015 mg/dl Or 10 RBC/µL | 5 to 10 RBC/μL |
| SPECIFIC GRAVITY | 1.000 to 1.030 | 1.000 to 1.030 |
| LEUKOCYTES | Trace to +++ | Trace to +++ |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing the interconnectedness of health and human services.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
JAN - 7 2005
Ms. Nitza Katz Vice President Cenogenics Corporation 100 Route 520 Drawer 308 Morganville, NJ 07751
Re: K042641
Trade/Device Name: CHEMVIEW-10TM Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL, KHE Dated: December 21, 2004 Received: December 22, 2004
Dear Ms. Katz:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w your to ought finding of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Totallar 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/industry/support/index.html
Sincerely yours,
Camelia B. Rooks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: _ CHEMVIEW
Indications For Use:
CHEMVIEW-10™ is a visual qualitative and semi-quantitative test for the determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity and leukocytes in urine. These metabolites are useful in the evaluation of renal, urinary and metabolic disorder.
The product will be marketed to physicians' office laboratories, clinics, hospitals and reference laboratories.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Carol C Jenson
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042641