(19 days)
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No
The device description and performance studies focus on the chemical reagents and their performance in standard laboratory tests, with no mention of AI or ML.
No
This device is for in vitro diagnostic (IVD) use, specifically as reagents, buffers, and standards for determining Na+, K+, and Cl- levels in serum, not for direct therapeutic treatment on a patient.
No
The device consists of reagents for determining the concentration of ions (Na+, K+, Cl-) in serum. These reagents are used with Olympus AU Chemistry Systems, which are analytical instruments. While the results from these tests can be used for diagnostic purposes, the reagents themselves are "In Vitro Diagnostic Solutions" that facilitate the test, not the diagnostic device itself that interprets the results for diagnosis. The "Intended Use" states they are "for the determination of" these ions, which is a measurement function, not a direct diagnostic one by the reagents themselves.
No
The device description explicitly states the products are "In Vitro Diagnostic Solutions," which are chemical reagents, not software.
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 reagents are "intended for use as ISE Reagents for the determination of Na+, K+, and Cl- for the Olympus® AU Clinical Chemistry Systems." This describes a product used to perform tests on samples taken from the human body (serum) to provide information about a person's health.
- Device Description: The "Device Description" section clearly identifies the products as "In Vitro Diagnostic Solutions."
- Performance Studies: The document describes performance studies (precision and correlation) conducted on patient serum samples, which is typical for IVD devices to demonstrate their analytical performance.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. The description provided for these reagents aligns perfectly with this definition.
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Intended Use / Indications for Use
The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Na+, K+, and Cl- for the Olympus® AU Clinical Chemistry Systems.
The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Na+, K+ and Cl in serum by ISE.
The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na+ and Cl- in serum samples on the Olympus® AU Chemistry Systems.
The ISE High and Low Standards are intended to provide calibration points for the Na+, K+ and Cl- Electrodes on the Olympus® AU ISE systems.
Product codes (comma separated list FDA assigned to the subject device)
CGZ, JGS, CEM, JIX
Device Description
pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for the following: (1) pHoenix ISE Buffer, (2) ISE Internal Reference Solution and (3) ISE Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Olympus® AU Chemistry Systems. The ISE Buffer dilutes all measured patient samples for the quantitative determination of Na+, K+ and Cl- in serum by ISE. The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na+, K+ and Cl- in serum samples on the Olympus AU Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Na+, K+ and Cl- Electrodes on the ISE system. pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Olympus® Diagnostics Corporation.
The products encompassed by this 510 (k) submission are Class I (75JJG) and Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Olympus® Diagnostics. pHoenix uses a similar composition, description and packaging design as that used by Olympus® Diagnostics in its products.
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
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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)
- Method comparison: results obtained on an Olympus® AU Chemistry Systems calibrated with pHoenix products were compared with results obtained on the same analyzer calibrated with Olympus® AU products.
- Precision study: pHoenix products were installed on Olympus® AU Chemistry Systems and samples were measured over 20 runs. Precision data was collected from the analysis of 2 levels of serum controls measured 2 runs per day, 2 times per run for 20 days on Olympus AU Systems for Na+, K+, and Cl- calibrated with pHoenix standard reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed.
- Correlation with Olympus Diagnostics Standard Reagents: Correlation data was collected from 50 samples (patient serum samples, control samples and spiked samples) for Na+, K+, and Cl- measured on Olympus AU Clinical Chemistry Systems installed with pHoenix reagents (ISE Diluent, ISE Internal Reference Solutions and Standards) as compared with Olympus reagents separately. A Linear Regression Analysis was performed using pHoenix data as the independent X Variable and Olympus Data as the Dependent Y Variable in the equation Y = a + bX.
Key Results:
Precision Study (Typical Results):
Level 1:
Na+: Total N=80, Mean=122, STD=1.23, CV%=1.00; Run to Run N=20, Mean=122, STD=0.67, CV%=0.55
K+: Total N=80, Mean=4.6, STD=0.105, CV%=2.26; Run to Run N=20, Mean=4.6, STD=0.039, CV%=0.84
Cl-: Total N=80, Mean=70.5, STD=0.76, CV%=1.08; Run to Run N=20, Mean=70.5, STD=0.30, CV%=0.42
Level 2:
Na+: Total N=80, Mean=165, STD=1.43, CV%=0.87; Run to Run N=20, Mean=165, STD=0.61, CV%=0.37
K+: Total N=80, Mean=6.50, STD=0.062, CV%=0.96; Run to Run N=20, Mean=6.50, STD=0.028, CV%=0.44
Cl-: Total N=80, Mean=121, STD=0.82, CV%=0.68; Run to Run N=20, Mean=121, STD=0.47, CV%=0.39
Correlation with Olympus Diagnostics Standard Reagents (Typical Results):
Na+: N=50, Slope=1.06, Intercept=-4.9, Correlation Coefficient=0.998, Range=100 - 180
K+: N=50, Slope=1.03, Intercept=0.11, Correlation Coefficient=0.999, Range=3 - 10
Cl-: N=50, Slope=0.98, Intercept=4.8, Correlation Coefficient=0.997, Range=70 - 150
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.
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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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§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2016
Phoenix Diagnostics, Inc. Mr. Ram Nunna President 8 Tech Circle Natick, MA 01760
Re: K020148
Trade/Device Name: pHoenix ISE Reagents for Olympus® AU Chemistry Systems Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: II Product Code: CGZ, JGS, CEM, JIX Dated: January 14, 2002 Received: January 16, 2001
Dear Mr. Ram Nunna:
This letter corrects our substantially equivalent letter of February 4, 2002.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows the name "Katherine Serrano -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clear and easy to read, with a simple and modern typeface.
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 0 20148
Device Name: pHoenix ISE Reagents for Olympus® AU Chemistry Systems
Indications For Use:
Intended Use :-
The pHoenix ISE Reagents for Olympus® AU Chemistry Systems are intended for use as ISE Reagents for the determination of Nat, K+, and Cli for the Olympus® AU Clinical Chemistry Systems.
The ISE Buffer is intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cl in serum by ISE.
The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na * and Cl in serum samples on the Olympus® AU Chemistry Systems.
The ISE High and Low Standards are intended to provide calibration points for the Na , K+ and Cli Electrodes on the Olympus® AU ISE systems.
Image /page/2/Figure/9 description: The image shows a handwritten signature of "Alan Cooper" along with the text "Divisio" and "510(k)". Below the signature, there is a handwritten code "K020148". The text and code appear to be part of a document or form, possibly related to a division or section identified by the code.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Image /page/2/Figure/11 description: The image shows the concurrence of CDRH, Office of Device Evaluation (ODE). There is an arrow pointing to the left side of the image, which says "Prescription Use (Per 21 CFR 801.109)". On the right side of the image, it says "OR Over-The-Counter Use (Optional Format 1-2-96)".
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K 020149
FEB 0 4 2002
510 (k) Summary
pHoenix ISE Reagents for Olympus® AU Chemistry Systems
Olympus® Diagnostics was the original manufacturer of the Olympus® AU Clinical Systems. Olympus® Diagnostics manufactures these products in Ireland and distributes through Olympus America Inc., which is located in Melville, NY.
pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for the following: (1) pHoenix ISE Buffer, (2) ISE Internal Reference Solution and (3) ISE Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Olympus® AU Chemistry Systems. The ISE Buffer dilutes all measured patient samples for the quantitative determination of Na+, K+ and Cl- in serum by ISE. The ISE Internal Reference Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na+, K+ and CI- in serum samples on the Olympus AU Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Na+, K+ and C1- Electrodes on the ISE system. pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Olympus® Diagnostics Corporation.
The products encompassed by this 510 (k) submission are Class I (75JJG) and Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Olympus® Diagnostics. Listed below are pHoenix products and their Olympus® Diagnostics equivalents.
| pHoenix
Cat.# | Olympus
Cat. # | Description | Models | Class |
|------------------|-------------------|---------------------------------|--------|-------|
| TBD | AUH1011 | ISE Buffer | AU | 1 |
| TBD | AUH1017 | ISE Internal Reference Solution | AU | 1 |
| TBD | AUH1014 | ISE Low Standard | AU | 2 |
| TBD | AUH1015 | ISE High Standard | AU | 2 |
pHoenix uses a similar composition, description and packaging design as that used by Olympus® Diagnostics in its products. pHoenix has shown performance equivalence of its products to Olympus® Diagnostics products in the following manner:
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510 (k) Summary cont.
- Through a method comparison where results obtained on a Olympus® AU Chemistry . Systems calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Olympus® AU products; and
- Through a precision study where pHoenix products were installed on Olympus® AU . Chemistry Systems and samples were measured over 20 runs.
A summary of the results of these studies follows:
Precision data was collected from the analysis of 2 levels of serum controls measured 2 runs per day, 2 times per run for 20 days on Olympus AU Systems for Nat, K, and Cl calibrated with pHoenix standard reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed. Typical Results are as follows:
| Analyte | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| Na+ | Total | 80 | 122 | 1.23 | 1.00 | 120 | 124 |
| Run to Run | 20 | 122 | 0.67 | 0.55 | 121 | 123 | |
| K+ | Total | 80 | 4.6 | 0.105 | 2.26 | 4.4 | 4.8 |
| Run to Run | 20 | 4.6 | 0.039 | 0.84 | 4.6 | 4.7 | |
| Cl- | Total | 80 | 70.5 | 0.76 | 1.08 | 69 | 73 |
| Run to Run | 20 | 70.5 | 0.30 | 0.42 | 70 | 71 |
Level 2
Level 4
| Analyte | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| Na+ | Total | 80 | 165 | 1.43 | 0.87 | 163 | 167 |
| Run to Run | 20 | 165 | 0.61 | 0.37 | 164 | 166 | |
| K+ | Total | 80 | 6.50 | 0.062 | 0.96 | 6.4 | 6.6 |
| Run to Run | 20 | 6.50 | 0.028 | 0.44 | 6.4 | 6.6 | |
| Cl- | Total | 80 | 121 | 0.82 | 0.68 | 119 | 122 |
| Run to Run | 20 | 121 | 0.47 | 0.39 | 120 | 122 |
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510 (k) Summary cont.
Correlation with Olympus Diagnostics Standard Reagents
Correlation data was collected from 50 samples (patient serum samples, control samples and spiked samples) for Nat, K+, and CI measured on Olympus AU Clinical Chemistry Systems installed with pHoenix reagents (ISE Diluent, ISE Internal Reference Solutions and Standards) as compared with Olympus reagents separately. A Linear Regression Analysis was performed using pHoenix data as the independent X Variable and Olympus Data as the Dependent Y Variable in the equation Y = a + bX . Typical results are as follows:
| Analyte | N | Slope | Intercept | Correlation
Coefficient | Range |
|---------|----|-------|-----------|----------------------------|-----------|
| Na+ | 50 | 1.06 | -4.9 | 0.998 | 100 - 180 |
| K+ | 50 | 1.03 | 0.11 | 0.999 | 3 - 10 |
| Cl- | 50 | 0.98 | 4.8 | 0.997 | 70 - 150 |
I hope you find this information useful and informative.
Ram Nunna, President
1/14/02
Date
Date