PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

K013451 · Phoenix Diagnostics, Inc. · CGZ · Dec 18, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013451
• Device Name: PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
• Applicant: Phoenix Diagnostics, Inc.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Dec 18, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Intended Use

The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K+ and CI for the Roche Hitachi 700/900 series Clinical Chemistry Systems. The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cli in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.

Device Story

pHoenix ISE Reagents consist of a diluent, internal reference solution, and high/low standards designed for use on Roche Hitachi 700/900 series clinical chemistry systems. The reagents function as direct replacements for Roche Diagnostics equivalents. The diluent prepares patient serum samples for ion-selective electrode (ISE) analysis; the internal reference solution compensates for calibration drift; and the standards provide calibration points for Na+, K+, and Cl- electrodes. Used in clinical laboratory settings by trained technicians. Output consists of quantitative electrolyte concentration values derived from the host system's ISE module. Benefits include providing a compatible, cost-effective alternative for routine serum electrolyte testing, facilitating accurate clinical decision-making regarding patient electrolyte balance.

Clinical Evidence

Performance equivalence demonstrated via method comparison and precision studies comparing pHoenix ISE reagents to Roche Diagnostics predicate products. No clinical trial data provided; bench testing only.

Technological Characteristics

Chemical reagents (diluent, reference solution, standards) for ion-selective electrode (ISE) analysis. Designed for compatibility with Roche Hitachi 700/900 series clinical chemistry systems. No electronic components, software, or energy sources integral to the reagents themselves.

Indications for Use

Indicated for the quantitative determination of sodium (Na+), potassium (K+), and chloride (Cl-) in serum samples using the ISE module of Roche Hitachi 700/900 series 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

• Roche Diagnostics ISE Reagents (K013451)

Submission Summary (Full Text)

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# iagnostics,

NATICK, MA 01760 . TEL: [phone] . FAX: [phone]

### DEC 1 82001

Address:

### 510 K SUMMARY

K01345/

### pHoenix ISE Reagents for Roche/Hitachi Models 700/900 Series.

- Ram Nunna. 1. Submitter:
pHoenix Diagnostics, Inc.

8 Tech Circle

Natick, MA. 01760

508-655-8310 Phone:

Fax: [phone]

Contact Person: Ram Nunna

Date of Summary: 11/9/01

### 2. Device Name and Associated Information:

Device name: pHoenix ISB Reagents for Roche/Hitachi 700, 900 series.

Trade name: Same as above.

Common name: Same as above.

### Classification and Associated Information:

Classification: Calibrator, Multianalyte Mixture.

Device Classification: Class II

Panel: Chemistry 75

Product Code: JIX

3. pHoenix ISE Reagents for Roche/Hitachi 700/900 Series Clinical Chemistry Systems

are similar in composition and performance to Roche Diagnostics equivalents.

Attachment: Substantial equivalence comparison.

{1}------------------------------------------------

# agnostics.

· NATICK, MA 01760 · TEL: [phone] · FAX: [phone]

### 510 K Summary:

pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system. pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Roche Diagnostics Corporation. These reagents are intended to serve as a direct replacement to like named products manufactured by Roche Diagnostics. pHoenix uses a similar composition description and packaging design as used by Roche Diagnostics. pHoenix has shown performance equivalence of its products to Roche Diagnostics products in the following manner:

- 1. Through method comparison
- 2. Through precision study

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# iagnostics, II

TECH CIRCLE . NATICK, MA 01760 . TEL: [phone] . FAX: [phone]

#### Intended Use:

The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K+ and CI for the Roche Hitachi 700/900 series Clinical Chemistry Systems.

The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cli in serum by ISE.

The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems.

The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.

| Ram Nunna | |
|------------|---------|
| Signature: | |
| Date: | 11/9/01 |
| | K013451 |

510K Number

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ram Nunna Contact Person pHoenix Diagnostic Inc. DEC 1 8 2001 8 Tech Circle Natick, MA 01760

k013451 Re: Trade/Device Name: pHoenix ISE Reagents for Roche Hitachi 700/900 series Regulation Number: 21 CFR 862.1665; 21 CFR 862.1600; 21 CFR.1170; 21 CFR 862.1150 Regulation Name: Sodium test system; Potassium test system; Chloride test system; Calibrator Regulatory Class: Class II; Class II, Class II, Class II Product Code: JGS; CEM; CGZ; JIX Dated: October 15, 2001 Received: October 18, 2001

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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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 1 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Steven Sutman

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

Device Name: pHoenix ISE Reagents for Roche Hitachi 700/900 series

Indications For Use:

Intended Use:

The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems.

The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE.

The ISE Internal Reference Solutions are intended as a means of compensating for The ISE Internal Kelefence Solutions are mination of NaT, K* and CI in serum samples on the Roche Hitachi Clinical Chemistry Systems.

The ISE High and Low Standards are intended to provide calibration points for the Nat, The IST Electrodes on the Roche Hitachi ISE system.

Thomas (Santo) In Jean Correa
Division Sign. Dep

Division of Clinical Laboratory Devices K 013451 510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Pex 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)