(18 days)
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No
The document describes an in vitro diagnostic calibration set for an existing analyzer and does not mention any AI or ML components in its description, intended use, or performance studies.
No
Explanation: The device is described as an "In Vitro Diagnostic Solution" for calibrating electrodes in a lab instrument, which means it is used for diagnostic purposes, not for treating or diagnosing a medical condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the products are "intended for invitro diagnostic use."
No
The device description clearly states the products are "In Vitro Diagnostic Solutions" and a "Calibration Set" consisting of "2 levels," indicating physical reagents, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The products encompassed by this request are intended for invitro diagnostic use..."
- Function: The device is a calibration set for electrodes used in a Roche Cobas ISE module. This module is used to measure Nat, K+, and Cli in samples, which are common in vitro diagnostic tests.
- Context: The submission is a 510(k) for a Class II In Vitro Diagnostic Solution. This regulatory classification is specifically for IVD devices.
The information provided strongly indicates that this device is intended to be used outside of the body to examine specimens (like serum) for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The products encompassed by this request are intended for invitro diagnostic use and are intended for use in calibrating Nat, K+, Cli electrodes in Roche Cobas ISE module. Roche is the original equipment manufacturer for the analyzer and predicate reagents. phoenix electrolyte calibration set is intended for use in playe of like named products manufactured by Roche Diagnostics.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. The Calibration Set consists of 2 levels and is intended for use in calibrating Na*, K* and CI on the Roche® Cobas™ ISE Module. Roche Diagnostics is the original equipment manufacturer (OEM) of the system.
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)
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 a on Roche® Cobas™ ISE Module calibrated with pHoenix calibrator reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed. Typical results are as follows:
Level 1:
Na+ Total: N=80, Mean=120.0, STD=1.50, CV%=1.20, Min=117, Max=122
Na+ Run to Run: N=20, Mean=120.0, STD=0.80, CV%=0.60, Min=118, Max=122
K+ Total: N=80, Mean=2.0, STD=0.110, CV%=5.0, Min=1.85, Max=2.15
K+ Run to Run: N=20, Mean=2.0, STD=0.040, CV%=1.5, Min=1.90, Max=2.10
Cl- Total: N=80, Mean=100.0, STD=0.60, CV%=0.60, Min=97, Max=102
Cl- Run to Run: N=20, Mean=100.0, STD=0.25, CV%=0.30, Min=98, Max=101
Level 4:
Na+ Total: N=80, Mean=165, STD=1.20, CV%=0.70, Min=162, Max=167
Na+ Run to Run: N=20, Mean=165, STD=0.70, CV%=0.40, Min=163, Max=167
K+ Total: N=80, Mean=6.50, STD=0.07, CV%=1.0, Min=6.4, Max=6.6
K+ Run to Run: N=20, Mean=6.50, STD=0.04, CV%=0.6, Min=6.4, Max=6.5
Cl- Total: N=80, Mean=146, STD=0.80, CV%=0.50, Min=144, Max=148
Cl- Run to Run: N=20, Mean=146, STD=0.60, CV%=0.40, Min=125, Max=148
Accuracy by Correlation with Roche Standard Reagents:
Correlation data was collected from patient serum samples and control samples for Na", K* and CI measured on a Roche® Cobas™ ISE Module calibrated with pHoenix reagents as compared with Roche reagents separately. A Linear Regression Analysis was performed using pHoenix data as the independent X Variable and Roche Data as the Dependent Y Variable in the equation Y = a + bX. Typical results are as follows:
Na+: N=50, Slope=1.01, Intercept=1.1, Correlation Coefficient=0.990, Range=120-180
K+: N=50, Slope=0.980, Intercept=1.1, Correlation Coefficient=0.990, Range=2.5-7.5
Cl-: N=50, Slope=0.990, Intercept=1.1, Correlation Coefficient=0.980, Range=78-120
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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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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510 (k) Summary
pHoenix Electrolyte Calibration Set for the Roche® Cobas™ ISE Module
The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. The Calibration Set consists of 2 levels and is intended for use in calibrating Na*, K* and CI on the Roche® Cobas™ ISE Module. Roche Diagnostics is the original equipment manufacturer (OEM) of the system.
The pHoenix products stated are currently cleared under docket K902675. Information herein will support pHoenix's position to extend the intended use of these products to the Roche® Cobas™ ISE Module. The Roche® Cobas™ ISE Module measures Na*, K*, and CI by using Ion Selective Electrode Technology. The pHoenix Calibrator Reagents are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics. pHoenix Product 17-200 and 17-201 are equivalent to Roche Product 44224.
pHoenix uses a similar composition, description and packaging design as that used by Roche Diagnostics in its products. pHoenix has shown performance equivalence of its products to Roche Diagnostic products in the following manner:
- Through a method comparison where results obtained on Roche® Cobas™ ISE . Module Chemistry Systems calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Roche products; and
- Through a precision study where pHoenix products were installed on Roche® . Cobas 114 ISE Module and samples were measured over multiple 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 a on Roche® Cobas™ ISE Module calibrated with pHoenix calibrator 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 | 120.0 | 1.50 | 1.20 | 117 | 122 |
| Run to Run | 20 | 120.0 | 0.80 | 0.60 | 118 | 122 | |
| K+ | Total | 80 | 2.0 | 0.110 | 5.0 | 1.85 | 2.15 |
| Run to Run | 20 | 2.0 | 0.040 | 1.5 | 1.90 | 2.10 | |
| Cl- | Total | 80 | 100.0 | 0.60 | 0.60 | 97 | 102 |
| Run to Run | 20 | 100.0 | 0.25 | 0.30 | 98 | 101 |
Level 2
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510 (k) Summary Cont.
Level 4
| Analyte | N | Mean | STD | CV% | Min | Max | |
|---|---|---|---|---|---|---|---|
| Na+ | Total | 80 | 165 | 1.20 | 0.70 | 162 | 167 |
| Run to Run | 20 | 165 | 0.70 | 0.40 | 163 | 167 | |
| K+ | Total | 80 | 6.50 | 0.07 | 1.0 | 6.4 | 6.6 |
| Run to Run | 20 | 6.50 | 0.04 | 0.6 | 6.4 | 6.5 | |
| Cl- | Total | 80 | 146 | 0.80 | 0.50 | 144 | 148 |
| Run to Run | 20 | 146 | 0.60 | 0.40 | 125 | 148 |
Accuracy by Correlation with Roche Standard Reagents
Correlation data was collected from patient serum samples and control samples for Na", K* and CI measured on a Roche® Cobas™ ISE Module calibrated with pHoenix reagents as compared with Roche reagents separately. A Linear Regression Analysis was performed using pHoenix data as the independent X Variable and Roche 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 | 1.01 | 1.1 | 0.990 | 120 - 180 |
| K+ | 50 | 0.980 | 1.1 | 0.990 | 2.5 - 7.5 |
| Cl- | 50 | 0.990 | 1.1 | 0.980 | 78 - 120 |
I hope you find this information useful and informative.
Ram Nunna, President
1/11/02
Data
Date
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 01 2002
Mr. Ram Nunna President pHoenix Diagnostic Inc. 8 Tech Circle Natick, MA 01760
Re: K020129
Trade/Device Name: pHoenix Electrolyte Calibration Set for the Roche® Cobas™ ISE Module Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: November 2, 2001 Received: January 14, 2002
Dear Mr. Nunna:
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.
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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 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/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K020129
Device Name: pHoenix Electrolyte Calibration Set for the Roche® Cobas™ ISE Module
Indications For Use:
Intended Use:
The products encompassed by this request are intended for invitro diagnostic use and are intended for use in calibrating Nat, K+, Cli electrodes in Roche Cobas ISE module. Roche is the original equipment manufacturer for the analyzer and predicate reagents. phoenix electrolyte calibration set is intended for use in playe of like named products manufactured by Roche Diagnostics.
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K020129 |
|---|---|
| --------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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)