(131 days)
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No
The summary describes a semi-automated benchtop analyzer using reflectance spectroscopy to measure analytes on urine test strips. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on correlation with a predicate device, precision, and linearity, which are standard evaluations for this type of device and do not suggest the use of AI/ML.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for measuring analytes in urine to evaluate renal, urinary, and metabolic disorders. It does not provide direct therapy to a patient.
Yes
The device is described as an "Urine Chemistry Analyzer" intended for "in vitro measurement of ... analytes" useful in the "evaluation of renal, urinary, and metabolic disorders," which directly points to its role in diagnosing or aiding in the diagnosis of various medical conditions.
No
The device description explicitly states it is a "semiautomated benchtop instrument" and a "semi-automated benchtop urine chemistry analyzer," indicating it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for the in vitro measurement of the following analytes...". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Measurement of Analytes: The device measures specific chemical components (analytes) in a biological sample (urine). This is a core function of IVDs used for diagnostic purposes.
- Use with Specific Reagents: The device is intended for use only with "iChem 10 SG Urine Chemistry Strips," which are reagents used in the in vitro testing process.
- Diagnostic Purpose: The measurements are described as "useful in the evaluation of renal, urinary, and metabolic disorders," indicating a diagnostic purpose.
- Healthcare Professional Use: While not exclusively defining an IVD, the intended user being healthcare professionals aligns with the typical use of diagnostic devices in a clinical setting.
The combination of these factors clearly indicates that the iChem100 Urine Chemistry Analyzer is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem 10 SG Urine Chemistry Strips only (Glucose, Protein, Bilirubin, Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite, Leukocyte Esterase, Ascorbic Acid and Color). The iChem 100 is intended for use exclusively by healthcare professionals. The results obtained from the iChem 100 are useful in the evaluation of renal, urinary, and metabolic disorders.
The iChem100 Urine Chemistry Analyzer (iChem100) is a semiautomated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals.
These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, JMA, JJB, JIN, JMT, CEN, JIR, CDM, JJQ, LJX, KQO
Device Description
The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem10 SG Urine Chemistry Strips.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical studies were conducted to evaluate the performance of the iChem 100 Automated Urine Analyzer. A correlation study demonstrated substantial equivalence when results from the iChem 100 were compared to the predicate device. Additional studies for precision and linearity demonstrated acceptable performance of the iChem 100 System for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
and bing the crucility of sife to recome everywhere
0602
Image /page/0/Picture/2 description: The image shows the word "Iris" in a stylized font. A curved line is above the "I" in "Iris", adding a design element to the logo. The font is bold and appears to be sans-serif. The overall design is simple and modern.
JUN 1 3 2006
510(k) Summary
OWNER'S NAME AND ADDRESS
Iris Diagnostics, a Division of IRIS International Inc. 9172 Eton Avenue Chatsworth, CA 91311
Primary Contact: Gerald J. Haddock, P.E. Phone: (818) 709-1244 ext. 129 Fax: (818) 700-9661
Date of Summary: March 1, 2006
DEVICE NAME:
Proprietary Name: iChem 100™ Urine Chemistry Analyzer Common/Usual Name: Urine Analyzer Classification Name: Automated Urinalysis System
PREDICATE DEVICE:
ARKRAY AUTION JET "AJ-4270 Urine Analyzer (K030600)
DEVICE DESCRIPTION:
The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem10 SG Urine Chemistry Strips.
INTENDED USE:
The iChem" 100 Urine Chemistry Analyzer is a semi-automated benchtop instrument for the rapid analysis of urine test strips. The iChem100 is designed to analyze and generate results for iChem 10 SG Urine Chemistry Strips only (Glucose, Protein, Bilirubin, Urobilinogen, pH, Specific Gravity,
Iris Diagnostics Division
图16 769 194 Free John William
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INTENDED USE (CONTINUED):
Blood, Ketones, Nitrite, Leukocyte Esterase, Ascorbic Acid and Color). The iChem 100 is intended for use exclusively by healthcare professionals. The results obtained from the iChem 100 are useful in the evaluation of renal, urinary, and metabolic disorders
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The indicated use of the proposed and predicate urine analyzers is the same. Both systems (instruments and associated strips) provide qualitative and semi-quantitative measurements of urine analytes using multi-parameter test strips.
The overall design of the proposed iChem 100 Urine Analyzer is very similar to the predicate. Both of these analyzers are semi automated, requiring that the user dip a test strip in the urine and place the test strip on a tray in the analyzers then time the reaction on the strip and automatically move the test strip to the Optical Block for analysis.
The proposed iChem 100 Urine Analyzer and the predicate AUTION JET™ AJ-4270 use reflectance spectroscopy for the measurement of all urine analytes. The proposed iChem 100 Urine Analyzer, and the predicate AUTION JET use reflectance spectroscopy for urine color determination. The proposed device implements the sensing function with a CMOS camera, compared to a photodiode used on the predicate device. Both units are microprocessor controlled.
The iChem 100 Urine Analyzer is indicated for use with iChem 10 SG Urine Chemistry test strips. The proposed iChem 10 SG strips are similar to the AUTION Sticks10EA that are indicated for use with the predicate AUTION JET AJ-4270, with the exception that the iChem 10 SG test strips contain a reagent pad for the measurement of Ascorbic Acid. The measurement of ascorbic acid on the iChem 100 is intended as a warning to the operator of potential interference with other tests due to elevated levels of ascorbic acid. The AUTION Sticks 10EA do not contain a reagent pad for the measurement of Ascorbic Acid
The mechanisms of action for the chemical reactions used for the determination of urinary analytes, including glucose and occult blood, are similar for the proposed iChem 10 SG strips and the predicate AUTION JET™ 10 EA test strips.
PERFORMANCE TESTING
Non-clinical studies were conducted to evaluate the performance of the iChem 100 Automated Urine Analyzer. A correlation study demonstrated substantial equivalence when results from the iChem 100 were compared to the predicate device. Additional studies for precision and linearity demonstrated acceptable performance of the iChem 100 System for its intended use.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus in the logo is a modern interpretation, featuring three curved lines that converge at the bottom, resembling a stylized representation of a staff with snakes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Gerald J. Haddock P.E. Director, Quality Assurance and Regulatory Affairs Iris Diagnostics, a Division of IRIS International, Inc. 9172 Eton Avenue Chatsworth, CA 91311
JUN 1 3 2006
K060280 Re:
Trade/Device Name: iChem™ 100 Urine Chemistry Analyzer and iChem™ 10 SG strips Regulation Number: 21 CFR§862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, JMA, JJB, JIN, JMT, CEN, JIR, CDM, JJQ, LJX, KQO Dated: June 2, 2006 Received: June 3, 2006
Dear Mr. Haddock:
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 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 (QS) 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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060280
iChem™ 100 Urine Chemistry Analyzer and iChem™ 10 SG strips Device Name:
Indications For Use: The iChem100 Urine Chemistry Analyzer (iChem100) is a semiautomated benchtop urine chemistry analyzer intended for the in vitro measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. The iChem100 is intended for use only with iChem 10 SG Urine Chemistry Strips provided by Iris Diagnostics and is intended for use exclusively by healthcare professionals.
These measurements are useful in the evaluation of renal, urinary, and metabolic disorders.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060270