CHEMVIEW-10 by CENOGENICS CORP. | FDA 510(k) Summary

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.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the CHEMVIEW-10™ Urinalysis Test Strips, structured according to your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided text. Instead, the study aims to demonstrate "substantial equivalence" to the predicate device (Roche Chemstrip®) through high agreement percentages. The reported device performance is presented as the agreement with the predicate.

Analyte	Acceptance Criteria (Implied)	Reported Device Performance (Agreement with Predicate)	Basis for Agreement
Glucose	High agreement with predicate	99.5%	Same color block
		100%	Within one color block
Occult Blood	High agreement with predicate	86.7%	Same color block
		97.34%	Within one color block

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: A total of 188 specimens were tested.
Data Provenance: The comparison studies were conducted at three reference laboratories. The specimens included "Fresh Urine specimens submitted to the laboratories for urinalysis as well as spiked urine specimens." This indicates a mix of naturally occurring clinical samples and possibly artificially altered samples, and the study is prospective in nature, as specimens were tested simultaneously with both devices. The country of origin is not explicitly stated, but the company is in Morganville, NJ, USA, and the FDA review is for the US market, suggesting data是从美国收集的.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text does not specify the number of experts used to establish the ground truth or their qualifications. The comparison is made against the Roche Chemstrip® urinalysis reagent test strips, which itself serves as a reference, rather than an independent expert reading of a gold standard.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. The performance is reported as a direct agreement between the "CHEMVIEW-10™" and the "Roche Chemstrip®" results. There's no mention of multiple readers or steps to resolve discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is for a visual, qualitative, and semi-quantitative test strip, not an AI-assisted diagnostic device where human readers interact with AI. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the CHEMVIEW-10™ is a visual test strip designed for human interpretation, not an algorithm. Therefore, "algorithm only without human-in-the-loop performance" doesn't fit the context of this device. The performance data is essentially the "standalone" performance of the test strip when read by a human.

7. The Type of Ground Truth Used

The "ground truth" for this study is the results obtained from the predicate device, Roche Chemstrip® urinalysis reagent test strips. The study establishes substantial equivalence by comparing results from the CHEMVIEW-10™ to those from the legally marketed predicate device.

8. The Sample Size for the Training Set

The text does not mention a separate training set. This is a traditional device comparison study and not an AI/machine learning study that typically involves training sets. The 188 specimens appear to be the only dataset described for performance evaluation.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or applicable in this context, the method for establishing its ground truth is not provided.

Summary

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K042641

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

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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1. 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.
1. 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.
1. 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:

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

Regulation Number and Section

§ 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.