(62 days)
Multi-parameter test strips to measure certain constituents in the urine either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Chemstrip® 5 OB, 7 and 10 MD urine test strips are inert plastic strips to which are attached different reagent pads for determining specific gravity, pH, indication of leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine.
The Chemstrip 5 OB test strip is a multi-parameter urinalysis test strip, which measures leukocytes, blood/hemoglobin, nitrite, protein and glucose in the urine.
The Chemstrip 7 test strip is a multi-parameter urinalysis test strip, which measures pH, ketone, leukocytes, blood/hemoglobin, nitrite, protein and glucose in the urine.
The Chemstrip 10 MD test strip is a multi-parameter urinalysis test strip which measures specific gravity, pH, ketones, leukocytes, blood/hemoglobin, nitrite, protein, urobilinogen, bilirubin and glucose in the urine.
The test papers are attached to the strip with a nylon mesh and certain test papers have an inert absorbent paper located between the test area and the strip.
The provided document describes the Roche Diagnostics Chemstrip® 5 OB, Chemstrip® 7, and Chemstrip® 10 MD urine test strips. The acceptance criteria and the study used to establish substantial equivalence are detailed in relation to sensitivity claims.
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for these devices relate to their sensitivity, i.e., the lowest concentration of an analyte that can generally be detected as positive. The study aims to demonstrate that the new Chemstrip® products have comparable sensitivity to the predicate device, the Bayer Multistix® 10 SG.
| Reagent | Predicate Device (Bayer Multistix® 10 SG Sensitivity) | New Device (Chemstrip® 101 Urine Analyzer Sensitivity) |
|---|---|---|
| Bilirubin | 0.4-0.8 mg/dL bilirubin | 0.8 - 1.5 mg/dL |
| Blood | 0.015-0.062 mg/dL hemoglobin | 5 - 20 Ery/uL |
| Glucose | 75-125 mg/dL glucose | 30 - 40 mg/dL |
| Ketone | 5-10 mg/dL acetoacetic acid | 5 - 15 mg/dL |
| Leukocytes | 5-15 cells/hpf in clinical urine | 30 - 35 Leu/uL |
| Nitrite | 0.06-0.1 mg/dL nitrite ion | 0.06 - 0.10 mg/dL |
| Protein | 15-30 mg/dL albumin | 25 - 32 mg/dL |
| Urobilinogen | Not specified for predicate | 1 - 2 mg/dL |
| Specific Gravity | Not specified for predicate | Not specified for new device sensitivity, only detection principle |
| pH | Not specified for predicate | Not specified for new device sensitivity, only detection principle |
Note on Differences: There are some discrepancies in the table provided. For instance, the "Blood" sensitivity for the predicate is in mg/dL of hemoglobin, while the new device is in Ery/uL (erythrocytes per microliter), making direct comparison challenging without further conversion. Similarly, Leukocytes are presented as cells/hpf (high power field) for the predicate and Leu/uL for the new device. The predicate device's sensitivity claims are explicitly noted to be for "contrived urine" and state that "lesser concentrations may be detected under certain conditions." The new device's sensitivity is presented as a range and notes "Because of inherent variability in clinical urines, lower levels may be detected under certain conditions."
The Study that Proves the Device Meets Acceptance Criteria:
The document describes a study that generated sensitivity data for the Chemstrip® products.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states that the sensitivity data was obtained using a "contrived urine pool." It does not specify the number of individual urine samples or patients included in this pool, nor the total number of tests performed.
- Data Provenance: The study was conducted using "contrived urine" and suggests that the data was generated by the manufacturer (Roche Diagnostics Corporation, based in Indianapolis, IN, USA). The document does not explicitly state the country of origin of clinical urine samples if any were used beyond the "contrived urine pool." The study appears to be retrospective in the sense that the data is presented as existing sensitivity values rather than describing a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The ground truth for sensitivity is typically established by precisely preparing analyte concentrations in a controlled matrix (like contrived urine) and verifying these concentrations using a highly accurate reference method. It's not usually established by human expert consensus in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Adjudication methods are generally not applicable to establishing sensitivity for chemical assays using contrived samples.
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:
This is not applicable to this device. The Chemstrip® products are multi-parameter urine test strips, not an AI-powered diagnostic device. The document mentions use with the Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer, which are automated readers, but no human-in-the-loop AI assistance is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone chemical test strip that can be read visually or with an analyzer. The sensitivity data provided is for the strips used with the Criterion II Urine Analyzer and the Chemstrip 101 Urine Analyzer. This represents the "algorithm only" performance (i.e., the analyzer's interpretation of the strip) for these specific parameters. The document also explicitly states the strips can be read "either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer," implying a degree of standalone performance for the strip itself, whether interpreted by an instrument or a human eye.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the sensitivity claims was established by using contrived urine pools with known, precisely prepared concentrations of analytes. This is a laboratory-based, analytical ground truth.
8. The sample size for the training set:
This information is not provided in the document. These are chemical test strips, and while there might have been internal development data for optimization, the concept of a "training set" as understood in machine learning (which often requires a large dataset for model training) does not directly apply here. The product's performance is based on the chemical reactions on the pads.
9. How the ground truth for the training set was established:
This information is not provided and is largely moot due to the nature of the device. For chemical test strips, the "ground truth" during development involves optimizing reagent concentrations and reaction kinetics to achieve desired sensitivity and specificity when exposed to known concentrations of analytes in a controlled environment.
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OCT - 8 2003
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250 |
| Contact Person: Jennifer TribbettDate Prepared: August 4, 2003 | |
| 2) Device name | Proprietary name: Chemstrip® 5 OB, Chemstrip® 7 and Chemstrip® 10MD test stripsCommon and Classification name: Urinary test system |
| 3) Predicatedevice | The Chemstrip 5 OB, 7 and 10 MD test strips are equivalent to otherurinalysis strips such as Bayer Multistix® 10 SG for use on the Clinitek 50Urine Analyzer (K960546). |
| 4) DeviceDescription | The Chemstrip 5 OB test strip is a multi-parameter urinalysis test strip, whichmeasures leukocytes, blood/hemoglobin, nitrite, protein and glucose in theurine. |
| The Chemstrip 7 test strip is a multi-parameter urinalysis test strip, whichmeasures pH, ketone, leukocytes, blood/hemoglobin, nitrite, protein andglucose in the urine. | |
| The Chemstrip 10 MD test strip is a multi-parameter urinalysis test strip whichmeasures specific gravity, pH, ketones, leukocytes, blood/hemoglobin, nitrite,protein, urobilinogen, bilirubin and glucose in the urine. | |
| 5) Intendeduse | Multi-parameter test strips to measure certain constituents in the urine eithervisually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer orCriterion II Urine Analyzer. These measurements are useful in the evaluation ofrenal, urinary and metabolic disorders. Chemstrip® 5 OB, 7 and 10 MD urinetest strips are inert plastic strips to which are attached different reagent pads fordetermining specific gravity, pH, indication of leukocytes, nitrite, protein,glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine. |
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- Substantial The table shown below describes the similarities and differences between the equivalence -Chemstrip 10 MD Urine Test Strip and the Chemstrip 5 OB and Chemstrip 7 Similarities and urine test strips. Differences
| Feature | Chemstrip 10 MD Test Strips for use on theChemstrip 101 Urine Analyzer (K983510) | Chemstrip 5 OB & 7Test Strips for use on theChemstrip 101 Urine Analyzer |
|---|---|---|
| Intended Use | The Chemstrip 10 MD urine test strip is a multi-parameter test strip used to measure certainconstituents in the urine either visually or on theRoche Diagnostics Chemstrip 101 Urine Analyzer.These measurements are useful in the evaluation ofrenal, urinary and metabolic disorders. | Same |
| ConstituentsDetected | Specific Gravity, Leukocytes, Nitrite, pH, Protein,Glucose, Ketones, Urobilinogen, Bilirubin, Blood | Reduced number of parameters |
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| Feature | Chemstrip® 10 MD Test Strips for use on theChemstrip 101 Urine Analyzer (K983510) | Chemstrip® 5 OB & 7Test Strips for use on theChemstrip 101 Urine Analyzer | ||
|---|---|---|---|---|
| TestPrinciple | Specific Gravity: In the presence of cations, protonsare released by a complexing agent and produce acolor change of the bromthymol blue indicator. | Not offered on the 5 or 7 | ||
| Leukocytes: Leukocytes in urine are detected by theaction of esterase, present in granulocytic leukocytes,which catalyzes the hydrolysis of an indoxylcarbonicacid ester to indoxyl. The indoxyl formed reacts witha diazonium salt to produce a color change. | Same | |||
| Nitrite: Nitrite reacts with an aromatic amine to givea diazonium salt, which by coupling with a furthercompound, yields a red-violet azo dye. | Same | |||
| pH: The test strip contains the indicators methyl redbromthymol blue.These give clearlyanddistinguishable colors over the pH range of 5-9. | Same as the 7, but not offered on the 5 | |||
| The detection of protein is based on theProtein:"protein error of pH indicators". The indicator3',3",5',5"-tetrachlorophenol-3,4,5,6-tetrabromosulfophthalein yields a color change in apositive reaction. | Same | |||
| Glucose detection is based on theGlucose:enzymatic glucose oxidase/peroxidase (GOD/POD)method. | Same | |||
| Sodium nitroprusside and glycine reactKetones:with acetoacetate and acetone in an alkaline mediumto form a violet dye complex. | Same as the 7, but not offered on the 5 |
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| Feature | Chemstrip® 10 MD Test Strips for use on theChemstrip 101 Urine Analyzer (K983510) | Chemstrip® 5 OB & 7Test Strips for use on theChemstrip 101 Urine Analyzer |
|---|---|---|
| TestPrinciple | Urobilinogen: Urobilinogen is coupled with 4-methoxybenzene-diazonium-tetrafluoroborate in anacid medium to form a red azo dye. | Not offered on the 5 or 7 |
| Bilirubin: Bilirubin detection is based on thecoupling reaction of a diazonium salt (2,6-dichlorobenzene-diazonium-tetrafluoroborate) withbilirubin in an acid medium which yields a colorchange. | Not offered on the 5 or 7 | |
| Blood: The chemical detection of blood is based onthe strong pseudoperoxidase action of erythrocytesand hemoglobin. Hemoglobin and myoglobin, ifpresent, catalyze the oxidation of the indicator by theorganic peroxide contained in the test paper. Intacterythrocytes hemolyze on the test paper and theliberated hemoglobin produces a green dot. | Same | |
| Test Pad | The test papers are attached to the strip with a nylonmesh and certain test papers have an inert absorbentpaper located between the test area and the strip. | Same |
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| Device | The table shown below describes the similarities and differences between the |
|---|---|
| Similarities and | Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD urine test strips and the |
| Differences | Bayer Multistix® 10 SG for use on the Clinitek 50 Urine Analyzer (K960546). |
| Feature | Chemstrip® 5 OB, Chemstrip® 7 andChemstrip® 10 MD Test Strips for use | Baver Multistix® 10 SG for use on theClinitek 50 Urine Analyzer K960546 | |||
|---|---|---|---|---|---|
| on the Chemstrip 101 Urine Analyzer | |||||
| Intended Use | Chemstrip 101 Urine Analyzer.renal, urinary and metabolic disorders. | The Chemstrip 5OB, 7 and 10 MD urine teststrip are multi-parameter test strips used tomeasure certain constituents in the urineeither visually or on the Roche DiagnosticsThesemeasurements are useful in the evaluation of | TheChemistry Analyzers. | Bayer Diagnostics Reagent StripsforUrinalysis are multi-parameter strips used tomeasure certain constituents in urine eithervisually or using the Clinitek family of Urine | |
| Constituentsdetected | ofSpecificCombinationsGravity,Leukocytes, Nitrite, pH, Protein, Glucose,Ketones, Urobilinogen, Bilirubin, Blood | Same | |||
| SensitivityClaims | followingtable summarizesThethesensitivity data obtained with the ChemstripCriterion II Urine Analyzer and the Chemstrip101 Urine Analyzer. This table lists the levelof analyte that is generally detectable aspositive when tested with a contrived urineBecause of inherent variability inpool.clinical urines, lower levels may be detectedunder certain conditions.(Note: Criterion II information remains thesame as previously indicated in the Chemstrip10 MD insert) | The following table lists the generally detectablelevels of analytes in contrived urine; however,because of the inherent variability of clinicalurines, lesser concentrations may be detectedunder certain conditions. | |||
| Reagent | Criterion II | Chemstrip 101 | Reagent | Sensitivity | |
| BilirubinBloodGlucoseKetoneLeukocytesNitriteProteinUrobilinogen | 1.0 mg/dL5 Ery/uL40 mg/dL5 mg/dL25 Leu/uL0.05 mg/dL18 mg/dL0.4 mg/dL | 0.8 - 1.5 mg/dL5 - 20 Ery/uL30 - 40 mg/dL5 - 15 mg/dL30 - 35 Leu/uL0.06 - 0.10 mg/dL25 - 32 mg/dL1 - 2 mg/dL | GlucoseBilirubinKetoneBloodProteinNitriteLeukocytes | 75-125 mg/dL glucose0.4-0.8 mg/dL bilirubin5-10 mg/dL acetoacetic acid0.015-0.062 mg/dL hemoglobin15-30 mg/dL albumin0.06-0.1 mg/dL nitrite ion5-15 cells/hpf in clinical urine |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 8 2003
Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K032437
Trade/Device Name: Chemstrip® 5 OB, 7 and 10 MD Urine Test Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: JIL: JRE; CEN; LJX; JIO: JMT; JIN; JJB; CDM; JIR Dated: August 4, 2003 Received: August 7, 2003
Dear Ms. Tribbett:
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. Iisting of devices, good nanufacturing 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 (OS) 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 (301) 594-3084. 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 Division 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Chemstrip® 5 OB, 7 and 10 MD Urine Test Strips
Indications for Use:
Multi-parameter test strips to measure certain constituents in the urine either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Chemstrip® 5 OB, 7 and 10 MD urine test strips are inert plastic strips to which are attached different reagent pads for determining specific gravity, pH, indication of leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson, Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032437
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.