CHEMVIEW-10

K042641 · Cenogenics Corp. · JIL · Jan 7, 2005 · Clinical Chemistry

Device Facts

• Record ID: K042641
• Device Name: CHEMVIEW-10
• Applicant: Cenogenics Corp.
• Product Code: JIL · Clinical Chemistry
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended 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.

Device Story

CHEMVIEW-10™ is a reagent test strip for urinalysis; provides visual qualitative and semi-quantitative results for ten analytes: urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity, and leukocytes. Used in clinical settings (physicians' offices, clinics, hospitals, reference labs) by healthcare professionals. Principle of operation involves colorimetric chemical reaction on test pads; user compares strip color changes against a reference chart to interpret results. Output assists clinicians in evaluating renal, urinary, and metabolic disorders. Benefits include rapid, point-of-care diagnostic screening for common urinary metabolites.

Clinical Evidence

Bench testing only. Comparison study conducted at three reference laboratories using 188 fresh and spiked urine specimens. Compared CHEMVIEW-10™ against Roche Chemstrip®. Glucose results showed 99.5% agreement within the same color block and 100% within one color block. Occult blood results showed 86.7% agreement within the same color block and 97.34% within one color block. No clinical patient outcome data provided.

Technological Characteristics

Solid-phase reagent test strip; 10 reagent areas per strip. Qualitative colorimetric enzymatic reaction principle. No energy source; visually read. Packaged in desiccated plastic vial. Shelf life: 2 years unopened, 6 months opened. No software or electronic components.

Indications for Use

Indicated for use in physicians' office laboratories, clinics, hospitals, and reference laboratories for the visual qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, protein, nitrite, pH, blood, specific gravity, and leukocytes in human urine.

Regulatory Classification

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.

Predicate Devices

• Roche Chemstrip®

Submission Summary (Full Text)

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K042641

## CENOGENICS CORPORATION 100 ROUTE 520 MORGANVILLE, NJ 07751 [phone] [phone] fax [e-mail]

## 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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- 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.
- 2. 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.
- 3. 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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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 [phone]. 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 [phone] or [phone] 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

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042641