(61 days)
No
The description focuses on reflectance photometry and automated measurements without mentioning AI/ML algorithms for analysis or interpretation.
No.
The device is used for semi-quantitative determination of various substances in urine, serving as a diagnostic tool rather than a therapeutic one.
Yes
The device is described as performing "semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine," which are measurements used to diagnose medical conditions.
No
The device description explicitly states it is "Urisys 2400 Urine Test Strips" used in conjunction with a "Urisys 2400 photometer," indicating a hardware component (test strips and photometer) is essential for its function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine". This describes a test performed on a biological sample (urine) outside of the body to provide information about a person's health status.
- Device Description: The description mentions it's used with a "photometer" to perform "reflectance measurements of test parameters on the Urisys 2400 Urine Test Strips". This further confirms it's a laboratory-based test using a device to analyze a sample.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K934042) and name ("Roche Diagnostics Chemstrip 10 S-UA test strips") is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
The definition of an IVD generally includes devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease or for the determination of the state of health. This device clearly fits this description.
N/A
Intended Use / Indications for Use
For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer.
Product codes
JIL, JIO
Device Description
The Urisys 2400 Urine Test Strips are used in conjunction with the Urisys 2400 photometer. The Urisys 2400 photometer is an automated urinalysis system, class I exempt device, regulation number 21CFR 862.2900. The Urisys 2400 photometer determines specific gravity, sample color, and sample clarity and reflectance measurements of test parameters on the Urisys 2400 Urine Test Strips.
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
Not Found
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 characteristics of the Urisys 2400 Urine Test Strips and the predicate device are provided in section IV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SEP 2 6 2001
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 576 - 3544 | |
| Contact Person: Kay A. Taylor | |
| Date Prepared: July 25, 2001 | |
| Device Name | Proprietary name: Urisys 2400 Urine Test Strip |
| Common name: Reagent Strip for Urinalysis | |
| Classification name: Urinary glucose, ketones, nitrite, protein, blood, bilirubin, urobilinogen, leukocytes (non-quantitative) and pH Test Systems | |
| Device Description | The Urisys 2400 Urine Test Strips are used in conjunction with the Urisys 2400 photometer. The Urisys 2400 photometer is an automated urinalysis system, class I exempt device, regulation number 21CFR 862.2900. The Urisys 2400 photometer determines specific gravity, sample color, and sample clarity and reflectance measurements of test parameters on the Urisys 2400 Urine Test Strips. |
:
1
510(k) Summary, Continued
| Intended use | For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer. |
|---|---|
| Indications for Use | For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer. |
| Substantial Equivalence | The Urisys 2400 Urine Test Strip is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Diagnostics Chemstrip 10 S-UA test strips (K934042). Both products are designed to provide semi-quantitative urinalysis results using chemistry reagent strips that include pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood reagent pad areas. |
Substantial equivalence similarities
The following table compares the Urisys 2400 Urine Test Strip with the predicate device.
| Feature | Urisys 2400 Urine Test
Strip | Chemstrip 10 S-UA |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For semi-quantitative
determination of pH,
leukocytes, nitrite, protein,
glucose, ketone bodies,
urobilinogen, bilirubin and
blood in urine by
reflectance photometry
with the Urisys 2400
photometer. | For the semi-quantitative
determination of Specific
Gravity, pH, Leukocytes,
Nitrite, Protein, Glucose,
Ketones, Urobilinogen,
Bilirubin and Blood in urine.
Intended for use visually or on
the Chemstrip Super UA
Automated Urine Analyzer. |
| Architecture | Reagent test paper, mesh
and absorbent paper
laminated on plastic strip. | Reagent test paper, mesh and
absorbent paper laminated on
plastic strip. |
| Calibration
method | Same | Calibration strips with specific
reflectance values for
calibration. |
| Storage | Store at 2°C-30°C. | At temperatures below 30°C,
do not freeze. |
2
510(k) Summary, Continued
Substantial equivalence similarities, continued
| Feature | Urisys 2400 Urine Test
Strip | Chemstrip 10 S-UA |
|---------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intrinsic color
compensation | Same | blank compensation pad
correction |
| Measurement
mode | Same, as well as urine
color through reflectance
readings of the
compensation pad | photometric reflectance for pH,
leukocytes, nitrite, protein.
glucose, ketones, urobilinogen,
bilirubin, erythrocytes |
Substantial equivalence differences
The following table compares the Urisys 2400 Urine Test Strips with the predicate device.
| Feature | Urisys 2400 Urine
Test Strips | Chemstrip 10 S-UA |
|-----------------------|-------------------------------------|----------------------------------|
| On-instrument storage | 14 days | up to 10 hours |
| Urine application | Sample dispensed onto
test strip | Test strip dipped into
sample |
Substantial equivalence performance characteristics The performance characteristics of the Urisys 2400 Urine Test Strips and the predicate device are provided in section IV.
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background is white.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 6 2001
Ms. Kay A. Taylor Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K012397
Trade/Device Name: Urisys 2400 Urinalysis Test System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (non-quantitative) test system Regulatory Class: Class II Product Code: JIL Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: ЛО Dated: July 25, 2001 Received: July 27, 2001
Dear Ms. Taylor:
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.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to begin marketing your device of your device to a legally marketed nouncedion. The PDA imania of successification 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 1 If you desire specific advice for your do the can and one of the Office of Compliance at additionally 607.10 for in This diaglestions on the promotion and advertising of your device, (201) 594-4568. Additional J. For quice 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 information on your responsionals. and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Sollass "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
Indications for Use Statement
510(k) Number (if known): NAA KO/2397
Device Name: Urisys 2400 Urinalysis Test System
Indications For Use:
For semi-quantitative determination of pH, leukocytes, nitrite, protein, glucose, ketone bodies, urobilinogen, bilirubin and blood in urine by reflectance photometry with the Urisys 2400 photometer.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _
(Optional Format 1-2-96)
Kesia Alexander Jordan Cooper
Division Sign Off
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012397
22