PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS

K023268 · Phoenix Diagnostics, Inc. · JIX · Nov 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023268
• Device Name: PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
• Applicant: Phoenix Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cli, Ca and Li* in human serum samples on the Roche AVL Systems. The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ in serum samples.

Device Story

pHoenix ISE Standards are liquid reagents used to calibrate Roche AVL clinical chemistry analyzers. These standards contain specific concentrations of electrolytes (Na+, K+, Cl-, Ca+, Li+); they serve as direct replacements for Roche Diagnostics-branded standards. The device is used in clinical laboratory settings by trained laboratory personnel. By providing known reference values, the standards allow the analyzer to calibrate its ion-selective electrode (ISE) sensors. This calibration ensures the accuracy of subsequent patient serum electrolyte measurements. Accurate electrolyte quantification is essential for diagnosing and monitoring various metabolic and physiological conditions. The device does not perform analysis itself but is integral to the operational accuracy of the Roche AVL system.

Clinical Evidence

Bench testing only. Precision study followed NCCLS EP5-T guidelines using 2 levels of serum controls measured over 20 days (N=80 per level). Method comparison performed on 50 samples (patient, control, spiked) comparing Roche AVL systems calibrated with pHoenix reagents vs. Roche reagents. Results showed high correlation (r > 0.99) and linear regression slopes near 1.0.

Technological Characteristics

Liquid chemical standards containing electrolytes (Na+, K+, Cl-, Ca+, Li+). Designed for use with Roche AVL ion-selective electrode (ISE) systems. No electronic components, software, or energy sources. Sterilization not applicable.

Indications for Use

Indicated for the calibration of Roche AVL systems to enable quantitative determination of Na+, K+, Cl-, Ca+, and Li+ in human serum samples.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Roche/AVL Diagnostics ISE Standards

Submission Summary (Full Text)

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K023268

NOV 1 5 2002

#### 510 (k) Summary

### pHoenix ISE Standards for Roche AVL Systems

AVL was the original manufacturer of the AVL Systems. Recently Roche Diagnostics acquired AVL and these Chemistry Systems are now referred to as Roche AVL Systems.

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for Standard A. B. and C for the Roche AVL Systems for the quantitative determination of Na+, K+, Cl-, Ca+ and Li+ in human serum. These Standards are used for the calibration of the Roche AVL Systems.

pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Roche/AVL Diagnostics.

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. These pHoenix ISE Standards are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics.

| pHoenix<br>Cat.# | Roche<br>Diagnostics Cat. # | Description and<br>Utilities | Analytes and Concentrations | | | | | | |
|------------------|-----------------------------|-------------------------------------|-----------------------------|-----|-------|------|-----|-----|------|
| | | | Na | K | Cl | Ca | Li | CO2 | pH |
| 4-001 | BP0936 | Standard A for<br>AVL 982,983,985 | 150 | 5 | 115 | 0.9 | 0.3 | / | / |
| 4-009 | BP0937 | Standard B for<br>AVL 985 | 100 | 1.8 | 72 | 1.5 | 0.3 | / | / |
| 4-010 | BP0938 | Standard C for<br>AVL 985 | 150 | 5 | 115 | 0.9 | 1.4 | / | / |
| 4-005 | BP0442 | Standard B for<br>AVL 982, 983 | 50 | 1.8 | 59.8 | 4 | / | / | / |
| 4-006 | BP1232 | Standard A for<br>AVL 984, 987, 988 | 150 | 5 | / | 1.25 | / | / | 7.38 |
| 4-007 | BP1218 | Standard B for<br>AVL 984, 987, 988 | 100 | 1.8 | / | 2.5 | / | / | 6.84 |
| 4-011 | BP1203 | Standard A for<br>AVL 986 | 150 | 5 | 125.3 | / | / | 25 | / |
| 4-012 | BP1201 | Standard B for<br>AVL 986 | 80 | 1.8 | 70.9 | / | / | 10 | / |

Listed below are pHoenix products, their Roche Diagnostics equivalents and usages on the Roche AVL instruments:

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### 510 (k) Summary cont.

pHoenix Diagnostics uses a similar composition and design as that used by Roche Diagnostics in its products. pHoenix has shown performance equivalence of its products to Roche Diagnostics products in the following manner:

- . Through a method comparison where results obtained on Roche AVL Systems calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Roche Diagnostics products; and
- Through a precision study where pHoenix products were installed on Roche AVL . systems and samples were measured over 20 runs.

A summary of the results of these studies is as 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 Roche AVL Systems for different electrolytes installed with pHoenix reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed. Typical Results are as follows:

## AVL 983

| Analyte | Level | N | Mean | STD | CV% | Min | Max |
|---------|-------|----|------|------|------|-----|-----|
| Na | 1 | 80 | 124 | 1.52 | 1.2 | 121 | 127 |
| Na | 3 | 80 | 164 | 2.6 | 1.6 | 162 | 166 |
| K | 1 | 80 | 1.93 | 0.11 | 5.5 | 1.7 | 2.2 |
| K | 3 | 80 | 6.5 | 0.06 | 0.96 | 6.4 | 6.6 |
| Cl | 1 | 80 | 85.6 | 1.4 | 1.7 | 82 | 89 |
| Cl | 3 | 80 | 148 | 0.82 | 0.56 | 146 | 149 |

#### AVL 984

| Analyte | Level | N | Mean | STD | CV% | Min | Max |
|---------|-------|----|------|-------|------|------|------|
| Na | 1 | 80 | 124 | 1.48 | 1.2 | 121 | 127 |
| Na | 3 | 80 | 165 | 1.75 | 1.06 | 162 | 170 |
| K | 1 | 80 | 1.91 | 0.105 | 5.5 | 1.7 | 2.2 |
| K | 3 | 80 | 6.7 | 0.101 | 1.52 | 6.4 | 6.8 |
| Ca | 1 | 80 | 2.36 | 0.112 | 4.76 | 2.2 | 2.6 |
| Ca | 3 | 80 | 0.84 | 0.014 | 1.69 | 0.81 | 0.87 |

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### 510 (k) Summary cont.

| △<br>1<br>1 | VL | તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જે |
|-------------|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |

| Analyte | Level | N | Mean | STD | CV% | Min | Max |
|---------|-------|----|------|-------|------|-----|-----|
| Na | 1 | 80 | 123 | 1.33 | 1.1 | 121 | 126 |
| Na | 3 | 80 | 165 | 1.73 | 1.05 | 162 | 170 |
| K | 1 | 80 | 1.84 | 0.08 | 4.43 | 1.7 | 2 |
| K | 3 | 80 | 6.6 | 0.12 | 1.85 | 6.4 | 6.8 |
| Li | 1 | 80 | 1.75 | 0.087 | 5 | 1.6 | 1.9 |
| Li | 3 | 80 | 2.56 | 0.1 | 3.71 | 2.4 | 2.8 |

#### Correlation with Roche AVL Reagents

Correlation data was collected from 50 samples (patient serum samples, control samples and spiked samples) for Na*, K*, Cl*, Ca* and Li* measured on Roche AVL Systems installed with pHoenix reagents as compared with Roche Diagnostics reagents separately. A Linear Regression Analysis was performed using Roche data as the independent X Variable and pHoenix Diagnostics Data as the Dependent Y Variable in the equation Y = a + bX. Typical results are as follows:

| | AVL Model | N | Slope | Intercept | Correlation<br>Coefficient | Range |
|-----|-----------|----|-------|-----------|----------------------------|-----------|
| Na+ | 983 | 50 | 1.03 | -1.36 | 0.992 | 75 - 178 |
| Na+ | 984 | 50 | 1.03 | -0.71 | 0.996 | 74 - 177 |
| Na+ | 985 | 50 | 1.03 | 0.98 | 0.994 | 75 - 177 |
| K+ | 983 | 50 | 1.005 | 0.32 | 0.996 | 2.9 - 6.7 |
| K+ | 984 | 50 | 1.001 | 0.29 | 0.998 | 2.8 - 6.7 |
| K+ | 985 | 50 | 0.98 | 0.402 | 0.997 | 3.1 - 6.8 |
| Cl- | 983 | 50 | 0.98 | 6.18 | 0.997 | 52 - 151 |
| Ca+ | 984 | 50 | 1.02 | 0.02 | 0.997 | 0.7 - 2.2 |
| Li+ | 985 | 50 | .989 | 0.03 | 0.998 | 0.3 - 2.4 |

I hope you find this information useful and informative.

Ram Nunna, President

8/20/02

Date

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three wavy lines forming the body and head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ram Nunna President pHoenix Diagnostics, Inc. 8 Tech Circle Natick, MA 01760

NOV 5 2002

Re: k023268

> Trade/Device Name: pHoenix ISE Standards for Roche AVL 982, 983, 984, 985, 986, 987, 988, 9110/9140, 9120/9130, 9180/9181

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 20, 2002 Received: September 30, 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. Iisting 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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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 ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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# INDICATIONS FOR USE STATEMENT

# 510(k) Number (if known): K_0 232 68

Device Name: pHoenix ISE Standards for Roche AVL 982, 983, 984, 985, 986, 987 988, 9110/9140, 9120/9130, 9180/9181

Indications For Use:

#### Intended Use:

The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cli, Ca and Li* in human serum samples on the Roche AVL Systems.

The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ in serum samples.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Seun Oguns

ision Sion-Off ivision of Clinical Laboratory Devices 510(k) Number .