(61 days)
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.
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.
The Urisys 2400 Urine Test Strips are intended for the semi-quantitative determination of various analytes in urine. The study presented compares its performance to the predicate device, the Roche Diagnostics Chemstrip 10 S-UA test strips (K934042).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria for each analyte that must be met for the Urisys 2400 Urine Test Strip to demonstrate substantial equivalence. Instead, the performance evaluation relies on a comparison of results between the Urisys 2400 system and the predicate device (Chemstrip 10 S-UA) when measuring patient samples, and a comparison against a reference method (microscopic evaluation for leukocytes, color comparison for others) for some analytes. The goal is to show comparable performance.
| Analyte | Acceptance Criteria (Implied: Comparable to Predicate/Reference) | Reported Device Performance (vs. Predicate/Reference) |
|---|---|---|
| pH | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 99.4% agreement on +/- 1 pH unit and 205 of 200 samples (p= <1e-8 for 95% CI) and 95% confidence interval for paired differences. The p-value and confidence interval information seem to be incorrectly transcribed or presented, as agreement is typically a percentage. The text likely intends to convey very high agreement. |
| Leukocytes | Comparable semi-quantitative results to predicate and reference (microscopic). | Compared with predicate (Chemstrip 10 S-UA): 98.7% agreement. Compared with microscopic evaluation: Agreement for positive/negative classification. Specific positive predictive value (PPV) and negative predictive value (NPV) were calculated. Details not fully provided in the excerpt but implied positive and negative agreement would be high. |
| Nitrite | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 100% agreement. |
| Protein | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 99.8% agreement. |
| Glucose | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 100% agreement. |
| Ketone Bodies | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 100% agreement. |
| Urobilinogen | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 99.8% agreement. |
| Bilirubin | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 99.8% agreement. |
| Blood | Comparable semi-quantitative results to predicate. | Compared with predicate (Chemstrip 10 S-UA): 99.8% agreement for patient samples and 100% agreement with spiked samples. Against a spiked sample reference: 100% agreement for the limit of detection studies confirming ability to detect blood at a low concentration (0.018 mg/dL hemoglobin). Specific method used to achieve this 100% agreement is not indicated; however, this is a positive indication that the Urisys 2400 is sensitive to the presence of blood and compares favorably against the Chemstrip 10 S-UA. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "patient samples". For pH, "205 of 200 samples" is referenced, which is likely a typo and probably means "200 samples" or "205 samples". For blood, both "patient samples" and "spiked samples" were used. More specific numbers for other analytes are not explicitly stated, but the overall context of comparing against a predicate implies a substantial number of test samples. For instance, the pH test result mentions "205 of 200 samples", which is unusual, but likely refers to a total of 205 samples with either 200 agreement or 200 used in a specific calculation.
- Data Provenance: Not explicitly stated, but clinical studies for medical devices are typically conducted in the country where the manufacturer seeks market approval or relevant clinical sites globally. Given the submitter is Roche Diagnostics Corporation in Indianapolis, IN, the data is likely from the United States. The study is prospective in nature, as it involves testing the new device and comparing its performance to a predicate and reference methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: For leukocytes, "microscopic evaluation" is used as a reference method, which is typically performed by trained clinical laboratory professionals or pathologists. For other analytes like pH, visual comparison for color scale changes might involve qualified laboratory personnel, but this is not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. For the comparison against the predicate device, it's a direct comparison of results. For analytes where a reference method (like microscopy for leukocytes) is used, the reference method itself serves as the ground truth, and the device's reading is directly compared to it. Any discrepancies would typically be reviewed by an expert.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance characteristics of the device (test strips read by an automated photometer) versus a predicate device and reference methods, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance study was done. The Urisys 2400 photometer automatically reads the test strips and determines the results. This is an algorithm-only evaluation, as the device provides semi-quantitative results without human intervention in the result interpretation process itself, only in sample application and loading.
7. The Type of Ground Truth Used
- Predicate Device Comparison: The performance of the predicate device (Chemstrip 10 S-UA) itself served as a primary "ground truth" or standard of comparison to demonstrate substantial equivalence for most analytes.
- Reference Methods:
- Microscopic Evaluation: Used for leukocytes. This is a common and established laboratory reference method.
- Spiked Samples: Used for blood to evaluate the limit of detection, where the known concentration of the analyte (hemoglobin) in the spiked sample serves as the ground truth.
- Color Comparison/Established Methods: For other analytes like pH, where visual or other established laboratory methods are typically used as references. The document doesn't detail these, but implies standard methods were used.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for a training set. This is a 510(k) submission, and the focus is on performance validation for substantial equivalence rather than explicit algorithm training data. The "training" for such electrochemical/optical systems is typically factory calibration and robust quality control, not data-driven machine learning algorithms in the sense of a training set for AI. The device uses reflectance photometry, meaning its internal "rules" are based on physical-chemical principles and pre-programmed algorithms to interpret color changes, not a distinct "training set" in the context of deep learning.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, there isn't a "training set" in the typical machine learning sense for this device. The "ground truth" for calibrating and setting up such an automated system involves using chemically defined standards, known positive and negative controls, and potentially a range of clinical samples with established values determined by reference laboratory methods, used during the device's development and manufacturing calibration to ensure accurate reflectance readings and interpretation. This process is part of quality control and manufacturing, rather than a distinct "training set" study for regulatory submission.
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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 Corporation9115 Hague RoadIndianapolis, IN 46250(317) 576 - 3544Contact Person: Kay A. TaylorDate Prepared: July 25, 2001 |
| Device Name | Proprietary name: Urisys 2400 Urine Test StripCommon name: Reagent Strip for UrinalysisClassification 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. |
:
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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 TestStrip | Chemstrip 10 S-UA |
|---|---|---|
| Intended Use | For semi-quantitativedetermination of pH,leukocytes, nitrite, protein,glucose, ketone bodies,urobilinogen, bilirubin andblood in urine byreflectance photometrywith the Urisys 2400photometer. | For the semi-quantitativedetermination of SpecificGravity, pH, Leukocytes,Nitrite, Protein, Glucose,Ketones, Urobilinogen,Bilirubin and Blood in urine.Intended for use visually or onthe Chemstrip Super UAAutomated Urine Analyzer. |
| Architecture | Reagent test paper, meshand absorbent paperlaminated on plastic strip. | Reagent test paper, mesh andabsorbent paper laminated onplastic strip. |
| Calibrationmethod | Same | Calibration strips with specificreflectance values forcalibration. |
| Storage | Store at 2°C-30°C. | At temperatures below 30°C,do not freeze. |
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510(k) Summary, Continued
Substantial equivalence similarities, continued
| Feature | Urisys 2400 Urine TestStrip | Chemstrip 10 S-UA |
|---|---|---|
| Intrinsic colorcompensation | Same | blank compensation padcorrection |
| Measurementmode | Same, as well as urinecolor through reflectancereadings of thecompensation 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 UrineTest Strips | Chemstrip 10 S-UA |
|---|---|---|
| On-instrument storage | 14 days | up to 10 hours |
| Urine application | Sample dispensed ontotest strip | Test strip dipped intosample |
Substantial equivalence performance characteristics The performance characteristics of the Urisys 2400 Urine Test Strips and the predicate device are provided in section IV.
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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.
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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
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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
§ 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.