(57 days)
Not Found
No
The summary describes a standard automated urine chemistry analyzer that measures chemical constituents using reagent sticks. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on correlation with a predicate device and reproducibility, not on the performance of an AI/ML algorithm.
No.
The document states that the device is a urine chemistry analyzer intended for routine urinalysis, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is a urine chemistry analyzer that determines the presence and concentration of various analytes in urine, which is used to aid in the diagnosis of various health conditions.
No
The device description explicitly states it is an "Automated urine chemistry analyzer," which is a hardware device. The performance studies also refer to comparing the "PocketChem™UA System" to another hardware system (Bayer System).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is for the "determination of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a patient's health status.
- Sample Type: The device analyzes urine, which is a biological specimen.
- Purpose: The purpose is to perform "routine urinalysis," which is a common diagnostic procedure.
- Professional Use: The indication for "professional use only" further supports its role in a clinical or laboratory setting for diagnostic purposes.
- Comparison to Predicate Device: The performance studies compare the device to a predicate device (Clinitek 50 / MULTISTIX 10SG Reagent Strips) which is also an IVD for urinalysis.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PocketChem™UA is a urine chemistry analyzer intended for the simultaneous detection of multiple chemistry analytes in urine. PocketChem™UA is intended for use in routine urinalysis – for the semiqualitative detection of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine at the following levels of detection:
| Analyte | Level of Detection |
|---|---|
| Glucose | 50 mg/dL - 1000 mg/dL |
| Protein | 15 mg/dL - 1000 mg/dL |
| Bilirubin | 0.5 mg/dL - Over (>6 mg/dL) |
| Urobilinogen | 2 mg/dL - Over (>8 mg/dL) |
| pH | 5.0 - 9.0 |
| Specific Gravity | 1.030 |
| Blood (Hemolysis and Non Hemolysis) | 0.06 mg/dL - 1.0 mg/dL |
| Ketones | 5 mg/dL - 150 mg/dL |
| Nitrite | NEG - 2+ |
| Leukocytes | 25 Leu/µL - 500 Leu/µL |
ARKRAY PocketChem™UA and AUTION Sticks 10TA are intended for professional use only.
The PocketChem™UA is a urine chemistry analyzer and is intended for use with the AUTION Sticks 10TA for the determination of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine. The tests provided by the use of the PocketChem™UA and the AUTION Sticks 10TA are considered routine urinalysis at the following levels of detection:
| Analyte | Level of Detection |
|---|---|
| Glucose | 50 mg/dL - 1000 mg/dL |
| Protein | 15 mg/dL - 1000 mg/dL |
| Bilirubin | 0.5 mg/dL - Over (>6 mg/dL) |
| Urobilinogen | 2 mg/dL - Over (>8 mg/dL) |
| pH | 5.0 - 9.0 |
| Specific Gravity | 1.030 |
| Blood (Hemolysis and Non Hemolysis) | 0.06 mg/dL - 1.0 mg/dL |
| Ketones | 5 mg/dL - 150 mg/dL |
| Nitrite | NEG - 2+ |
| Leukocytes | 25 Leu/µL - 500 Leu/µL |
For professional use only.
Product codes
JIL; JIP; KQO
Device Description
Automated urine chemistry analyzer - a urinalysis system for the measurement of certain physical properties and chemical constituents of 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
professional use only.
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
Three hundred and two (302) clinical samples were tested for routine urinalysis. 30 positive samples were found for glucose and 60 positive for blood.
Summary of Performance Studies
Product performance was compared to the Baver System (Clinitek50 & MULTISTIX 10SG). Three hundred and two (302) clinical samples were tested for routine urinalysis. 30 positive samples were found for glucose and 60 positive for blood. In comparison to the Bayer system, ARKRAY was proven to correlate results of 97.7% for Glucose and 100% for Blood for both negative and positive samples. The manual read of the AUTION Sticks 10TA compared to the PocketChem™UA System in correlated 100% of the samples. Reproducibility and precision was evaluated using control-matrix samples spiked with varying concentrations of glucose and blood; throughout the entire range of detection, including extreme negative and positive samples. The results confirmed the reproducibility and precision of the ARKRAY PocketChem™JA and the AUTION Sticks 10TA.
Key Metrics
97.7% for Glucose and 100% for Blood for both negative and positive samples (correlation).
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
510k Submission ARKRAY, Inc.
1622386
SEP 1 7 2002
510 (K) SUMMARY
Date of Summary
July 19, 2002
Product Name:
PocketChem™UA AUTION Stick 10TA
Sponsor & Manufacturer:
ARKRAY, Inc. 57 NISHI AKETA-CHO, HIGASHI-KUJO MINAMI-KU, KYOTO, 601-8045, JAPAN FDA Registration #: 961144
US Distributor
Thermo BioStar 331 S. 104th Street Louisville, CO 80027
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device:
Product: Clinitek 50 / MULTISTIX 10SG Reagent Strips Manufactured by: Bayer Corp 510k Number: K960546
Product Description:
Automated urine chemistry analyzer - a urinalysis system for the measurement of certain physical properties and chemical constituents of urine.
1
510k Submission ARKRAY. Inc.
Intended Use:
PocketChem™UA is a urine chemistry analyzer intended for the simultaneous detection of multiple chemistry analytes in urine. PocketChem™UA is intended for use in routine urinalysis – for the semiqualitative detection of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine at the following levels of detection:
| Analyte | Level of Detection |
|---|---|
| Glucose | 50 mg/dL - 1000 mg/dL |
| Protein | 15 mg/dL - 1000 mg/dL |
| Bilirubin | 0.5 mg/dL - Over (>6 mg/dL) |
| Urobilinogen | 2 mg/dL - Over (>8 mg/dL) |
| pH | 5.0 - 9.0 |
| Specific Gravity | 1.030 |
| Blood (Hemolysis and Non Hemolysis) | 0.06 mg/dL - 1.0 mg/dL |
| Ketones | 5 mg/dL - 150 mg/dL |
| Nitrite | NEG - 2+ |
| Leukocytes | 25 Leu/µL - 500 Leu/µL |
ARKRAY PocketChem™UA and AUTION Sticks 10TA are intended for professional use only.
Performance Characteristics:
ARKRAY PocketChem™UA and AUTION Stick 10 TA System detect 10 analytes measured in routine urinalysis.
ARKRAY PocketChem™ and AUTION Stick 10TA is substantially equivalent to the Clinitek 50 and MULTISTIX 10SG Reagent Strips manufactured by Bayer Corporation 510k number K960546.
Product performance was compared to the Baver System (Clinitek50 & MULTISTIX 10SG). Three hundred and two (302) clinical samples were tested for routine urinalysis. 30 positive samples were found for glucose and 60 positive for blood.
In comparison to the Bayer system, ARKRAY was proven to correlate results of 97.7% for Glucose and 100% for Blood for both negative and positive samples. The manual read of the AUTION Sticks 10TA compared to the PocketChem™UA System in correlated 100% of the samples.
Reproducibility and precision was evaluated using control-matrix samples spiked with varying concentrations of glucose and blood; throughout the entire range of detection, including extreme negative and positive samples. The results confirmed the reproducibility and precision of the ARKRAY PocketChem™JA and the AUTION Sticks 10TA.
2
510k Submission ARKRAY, Inc.
Conclusion:
ARKRAY PocketChem™UA and AUTION Sticks 10TA are substantially equivalent as an automated system and as manual-read strips to Bayer's Clinitek 50 and MULTISTIX 10SG Reagent Strips (K960546) as an automated urinalysis system and reagent strips for visual interpretation.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three curved lines representing the wings and body. The logo is surrounded by the text "U.S. HEALTH & HUMAN SERVICES DEPARTMENT" in a circular arrangement.
Public Health Service
198 Gaither Boar Rockville MD 20850
FP 1 7 2002
Arkray, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
Re: K022386
Trade/Device Name: PacketChem™UA & AUTION Stick 10TA Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL; JIP; KQO Dated: July 19, 2002 Received: July 22, 2002
Dear Ms. White:
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 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
510k Submission ARKRAY, Inc.
510(k) Number: Device Name:
PocketChem™UA & AUTION Stick 10TA
Indication for Use:
The PocketChem™UA is a urine chemistry analyzer and is intended for use with the AUTION Sticks 10TA for the determination of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite and leukocytes in urine. The tests provided by the use of the PocketChem™UA and the AUTION Sticks 10TA are considered routine urinalysis at the following levels of detection:
| Analyte | Level of Detection |
|---|---|
| Glucose | 50 mg/dL - 1000 mg/dL |
| Protein | 15 mg/dL - 1000 mg/dL |
| Bilirubin | 0.5 mg/dL - Over (>6 mg/dL) |
| Urobilinogen | 2 mg/dL - Over (>8 mg/dL) |
| pH | 5.0 - 9.0 |
| Specific Gravity | 1.030 |
| Blood (Hemolysis and Non Hemolysis) | 0.06 mg/dL - 1.0 mg/dL |
| Ketones | 5 mg/dL - 150 mg/dL |
| Nitrite | NEG - 2+ |
| Leukocytes | 25 Leu/µL - 500 Leu/µL |
For professional use only.
Jean Cooper
(Divi
Divi ces
510(x, KC22386
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use (Optional Format 1-2-96)