pHoenix ISE Reagents FOR Olympus AU Chemistry Systems

K020148 · Phoenix Diagnostics, Inc. · CGZ · Feb 4, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020148
• Device Name: pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
• Applicant: Phoenix Diagnostics, Inc.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Feb 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

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.

Device Story

pHoenix ISE Reagents serve as direct replacements for Olympus Diagnostics reagents on Olympus AU Clinical Chemistry Systems. System uses ISE Buffer to dilute patient serum samples; ISE Internal Reference Solution to compensate for calibration drift; and ISE High/Low Standards to calibrate Na+, K+, and Cl- electrodes. Used in clinical laboratory settings by trained technicians. Output consists of quantitative electrolyte concentration values displayed on the analyzer interface. Healthcare providers use these results to assess patient electrolyte status and guide clinical management. Benefits include maintaining continuity of testing using existing analyzer infrastructure with equivalent performance.

Clinical Evidence

Bench testing only. Precision study (N=80 per level, 20 days) evaluated total and run-to-run CV% for Na+, K+, and Cl- (Na+ CV% 0.87-1.00; K+ CV% 0.96-2.26; Cl- CV% 0.68-1.08). Method comparison (N=50) against Olympus reagents showed high correlation (r=0.997-0.999) across clinical ranges.

Technological Characteristics

In vitro diagnostic chemical reagents for ion-selective electrode (ISE) analysis. Includes buffer, reference solution, and calibration standards. Designed for use on Olympus AU Chemistry Systems. No specific materials of construction or software algorithms described; device functions as chemical consumables for existing hardware.

Indications for Use

Indicated for the quantitative determination of sodium (Na+), potassium (K+), and chloride (Cl-) in human serum samples using Olympus AU Clinical Chemistry Systems.

Regulatory Classification

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.

Predicate Devices

• Olympus Diagnostics ISE Buffer (AUH1011)
• Olympus Diagnostics ISE Internal Reference Solution (AUH1017)
• Olympus Diagnostics ISE Low Standard (AUH1014)
• Olympus Diagnostics ISE High Standard (AUH1015)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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.

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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<br>Cat.# | Olympus<br>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<br>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

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