(62 days)
No
The description focuses on chemical reagent pads and their visual or analyzer-based interpretation, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is a diagnostic tool used to measure constituents in urine for the evaluation of disorders, not to treat them.
Yes
The device measures "certain constituents in the urine" and states that "These measurements are useful in the evaluation of renal, urinary and metabolic disorders," which directly indicates its purpose is to aid in diagnosis.
No
The device description clearly states it is an "inert plastic strip" with "reagent pads" and "test papers attached to the strip with a nylon mesh," indicating it is a physical, hardware-based device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "measure certain constituents in the urine... useful in the evaluation of renal, urinary and metabolic disorders." This involves testing a sample (urine) taken from the human body to provide information about a person's health.
- Device Description: The description details test strips with reagent pads that react with specific substances in urine. This is a characteristic of in vitro diagnostic tests.
- Performance Studies: The document includes a summary of performance studies, specifically sensitivity data, which is a common requirement for demonstrating the performance of IVD devices.
- Predicate and Reference Devices: The mention of predicate and reference devices (other urine test strips and analyzers) further confirms that this device falls within the category of IVDs.
In summary, the device is designed to perform tests on a biological sample (urine) outside of the body to aid in the diagnosis or evaluation of medical conditions, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JRE, CEN, LJX, JIO, JMT, JIN, JJB, CDM, JIR
Device Description
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.
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 following table summarizes the sensitivity data obtained with the Chemstrip Criterion II Urine Analyzer and the Chemstrip 101 Urine Analyzer. This table lists the level of analyte that is generally detectable as positive when tested with a contrived urine pool. Because of inherent variability in clinical urines, lower levels may be detected under certain conditions.
| Reagent | Criterion II | Chemstrip 101 |
|---|---|---|
| Bilirubin | 1.0 mg/dL | 0.8 - 1.5 mg/dL |
| Blood | 5 Ery/uL | 5 - 20 Ery/uL |
| Glucose | 40 mg/dL | 30 - 40 mg/dL |
| Ketone | 5 mg/dL | 5 - 15 mg/dL |
| Leukocytes | 25 Leu/uL | 30 - 35 Leu/uL |
| Nitrite | 0.05 mg/dL | 0.06 - 0.10 mg/dL |
| Protein | 18 mg/dL | 25 - 32 mg/dL |
| Urobilinogen | 0.4 mg/dL | 1 - 2 mg/dL |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (generally detectable levels):
Bilirubin: 0.8 - 1.5 mg/dL (Chemstrip 101), 1.0 mg/dL (Criterion II)
Blood: 5 - 20 Ery/uL (Chemstrip 101), 5 Ery/uL (Criterion II)
Glucose: 30 - 40 mg/dL (Chemstrip 101), 40 mg/dL (Criterion II)
Ketone: 5 - 15 mg/dL (Chemstrip 101), 5 mg/dL (Criterion II)
Leukocytes: 30 - 35 Leu/uL (Chemstrip 101), 25 Leu/uL (Criterion II)
Nitrite: 0.06 - 0.10 mg/dL (Chemstrip 101), 0.05 mg/dL (Criterion II)
Protein: 25 - 32 mg/dL (Chemstrip 101), 18 mg/dL (Criterion II)
Urobilinogen: 1 - 2 mg/dL (Chemstrip 101), 0.4 mg/dL (Criterion II)
Predicate Device(s)
Reference Device(s)
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
OCT - 8 2003
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. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250 |
| | Contact Person: Jennifer Tribbett
Date Prepared: August 4, 2003 |
| 2) Device name | Proprietary name: Chemstrip® 5 OB, Chemstrip® 7 and Chemstrip® 10
MD test strips
Common and Classification name: Urinary test system |
| 3) Predicate
device | The Chemstrip 5 OB, 7 and 10 MD test strips are equivalent to other
urinalysis strips such as Bayer Multistix® 10 SG for use on the Clinitek 50
Urine Analyzer (K960546). |
| 4) Device
Description | 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. |
| 5) Intended
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. |
1
- 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 the
Chemstrip 101 Urine Analyzer (K983510) | Chemstrip 5 OB & 7
Test Strips for use on the
Chemstrip 101 Urine Analyzer |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use | The Chemstrip 10 MD urine test strip is a multi-
parameter test strip used to measure certain
constituents in the urine either visually or on the
Roche Diagnostics Chemstrip 101 Urine Analyzer.
These measurements are useful in the evaluation of
renal, urinary and metabolic disorders. | Same |
| Constituents
Detected | Specific Gravity, Leukocytes, Nitrite, pH, Protein,
Glucose, Ketones, Urobilinogen, Bilirubin, Blood | Reduced number of parameters |
2
-Continued-
| Feature | Chemstrip® 10 MD Test Strips for use on the
Chemstrip 101 Urine Analyzer (K983510) | Chemstrip® 5 OB & 7
Test Strips for use on the
Chemstrip 101 Urine Analyzer | | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--|--|
| Test
Principle | Specific Gravity: In the presence of cations, protons
are released by a complexing agent and produce a
color change of the bromthymol blue indicator. | Not offered on the 5 or 7 | | |
| | Leukocytes: Leukocytes in urine are detected by the
action of esterase, present in granulocytic leukocytes,
which catalyzes the hydrolysis of an indoxylcarbonic
acid ester to indoxyl. The indoxyl formed reacts with
a diazonium salt to produce a color change. | Same | | |
| | Nitrite: Nitrite reacts with an aromatic amine to give
a diazonium salt, which by coupling with a further
compound, yields a red-violet azo dye. | Same | | |
| | pH: The test strip contains the indicators methyl red
bromthymol blue.
These give clearly
and
distinguishable 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 the
Protein:
"protein error of pH indicators". The indicator
3',3",5',5"-tetrachlorophenol-3,4,5,6-
tetrabromosulfophthalein yields a color change in a
positive reaction. | Same | | |
| | Glucose detection is based on the
Glucose:
enzymatic glucose oxidase/peroxidase (GOD/POD)
method. | Same | | |
| | Sodium nitroprusside and glycine react
Ketones:
with acetoacetate and acetone in an alkaline medium
to form a violet dye complex. | Same as the 7, but not offered on the 5 | | |
3
-Continued-
| Feature | Chemstrip® 10 MD Test Strips for use on the
Chemstrip 101 Urine Analyzer (K983510) | Chemstrip® 5 OB & 7
Test Strips for use on the
Chemstrip 101 Urine Analyzer |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Test
Principle | Urobilinogen: Urobilinogen is coupled with 4-
methoxybenzene-diazonium-tetrafluoroborate in an
acid medium to form a red azo dye. | Not offered on the 5 or 7 |
| | Bilirubin: Bilirubin detection is based on the
coupling reaction of a diazonium salt (2,6-
dichlorobenzene-diazonium-tetrafluoroborate) with
bilirubin in an acid medium which yields a color
change. | Not offered on the 5 or 7 |
| | Blood: The chemical detection of blood is based on
the strong pseudoperoxidase action of erythrocytes
and hemoglobin. Hemoglobin and myoglobin, if
present, catalyze the oxidation of the indicator by the
organic peroxide contained in the test paper. Intact
erythrocytes hemolyze on the test paper and the
liberated hemoglobin produces a green dot. | Same |
| Test Pad | 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. | Same |
4
| 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 and
Chemstrip® 10 MD Test Strips for use | | | Baver Multistix® 10 SG for use on the
Clinitek 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 test
strip are multi-parameter test strips used to
measure certain constituents in the urine
either visually or on the Roche Diagnostics
These
measurements are useful in the evaluation of | The
Chemistry Analyzers. | Bayer Diagnostics Reagent Strips
for
Urinalysis are multi-parameter strips used to
measure certain constituents in urine either
visually or using the Clinitek family of Urine |
| Constituents
detected | of
Specific
Combinations
Gravity,
Leukocytes, Nitrite, pH, Protein, Glucose,
Ketones, Urobilinogen, Bilirubin, Blood | | | | Same |
| Sensitivity
Claims | following
table summarizes
The
the
sensitivity data obtained with the Chemstrip
Criterion II Urine Analyzer and the Chemstrip
101 Urine Analyzer. This table lists the level
of analyte that is generally detectable as
positive when tested with a contrived urine
Because of inherent variability in
pool.
clinical urines, lower levels may be detected
under certain conditions.
(Note: Criterion II information remains the
same as previously indicated in the Chemstrip
10 MD insert) | | | The following table lists the generally detectable
levels of analytes in contrived urine; however,
because of the inherent variability of clinical
urines, lesser concentrations may be detected
under certain conditions. | |
| | Reagent | Criterion II | Chemstrip 101 | Reagent | Sensitivity |
| | Bilirubin
Blood
Glucose
Ketone
Leukocytes
Nitrite
Protein
Urobilinogen | 1.0 mg/dL
5 Ery/uL
40 mg/dL
5 mg/dL
25 Leu/uL
0.05 mg/dL
18 mg/dL
0.4 mg/dL | 0.8 - 1.5 mg/dL
5 - 20 Ery/uL
30 - 40 mg/dL
5 - 15 mg/dL
30 - 35 Leu/uL
0.06 - 0.10 mg/dL
25 - 32 mg/dL
1 - 2 mg/dL | Glucose
Bilirubin
Ketone
Blood
Protein
Nitrite
Leukocytes | 75-125 mg/dL glucose
0.4-0.8 mg/dL bilirubin
5-10 mg/dL acetoacetic acid
0.015-0.062 mg/dL hemoglobin
15-30 mg/dL albumin
0.06-0.1 mg/dL nitrite ion
5-15 cells/hpf in clinical urine |
5
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),
6
Page 2 -
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
7
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)