PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER

K012987 · Phoenix Diagnostics, Inc. · JIX · Nov 7, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012987
• Device Name: PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
• Applicant: Phoenix Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

pHoenix Electrolyte Calibration Set for the Medica EasyLyte Calcium Analyzer is intended for use as The procedes to calibrate Nat, K+, Ca* and pH for the Medica EasyLyte Calcium Analyzer.

Device Story

Aqueous calibration set consisting of two standards (A and B) containing sodium, potassium, calcium, and buffers; designed as a direct replacement for Medica Corporation calibrators. Used in clinical laboratories to calibrate ion-selective electrodes (ISE) in the Medica EasyLyte Calcium Analyzer. Provides reference points for the analyzer to ensure accurate measurement of electrolytes and pH in patient samples. Enables healthcare providers to maintain analyzer performance for diagnostic testing.

Clinical Evidence

No clinical data. Performance equivalence established via bench testing, specifically method comparison and precision studies against the predicate device.

Technological Characteristics

Aqueous solution containing sodium, potassium, calcium, and buffers. Designed for use with ion-selective electrode (ISE) technology. No hazardous chemicals. Standalone calibration set.

Indications for Use

Indicated for the calibration of Na+, K+, Ca++, and pH electrodes in the Medica EasyLyte Calcium Analyzer within laboratory settings.

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

• Medica EasyLyte Calcium Analyzer (K943091)

Reference Devices

• Medica Easylyte Electrolyte Analyzer
• Nova Biomedical Electrolyte Analyzer

Submission Summary (Full Text)

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tics, Inc

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

### 510 K SUMMARY

- Ram Nunna 1. Submitter: Address: pHoenix Diagnostics Inc. 8 Tech Circle Natick. MA 01760 208-655-8310 Phone: [phone] Fax: Contact Person: Ram Nunna
Date of Summary: 11/01/01

NOV 0 7 2001

#### 2. Device Name and Associated Information:

Device Name: Electrolyte Calibration Set for Medica Easylyte Calcium Analyzer.

Trade Name: Same as above.

Common Name: Same as above.

#### Classification and Associated Information:

Classification: Calibrator, Multianalyte Mixture

Device Classification: II

Panel: Chemistry 75

Product Code: JIX

## 3. pHoenix Electrolyte Calibration Set is similar in composition and performance to

#### the following systems calibration set:

- 1. Medica Easylyte Electrolyte Analyzer.
- 2. Nova Biomedical Electrolyte Analyzer.

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Image /page/1/Picture/0 description: The image shows the logo for pHoenix Diagnostics, Inc. The text is in bold, black font. The word "pHoenix" is in a slightly smaller font than "Diagnostics, Inc."

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

Attachment: Substantial equivalence comparison.

- 4. 510 K Summary: Phoenix Electrolyte Calibration Set for Medica Easylyte Analyzer consists of two standards A and B for use in calibrating Nat, Kt, Cat+ and pH electrodes. The Medica Easylyte Calcium Analyzer measures Na , K , Ca + , and pH using ion selective electrode technology. pHoenix calibration set is intended to serve as direct replacement to similar calibrator manufactured by Medica Corporation. pHoenix uses similar composition, description and packaging design as that used by Medica Corporation in its calibration set. pHoenix has shown performance equivalence of its calibration set, to Medica Corporation calibration set, in the following manner:
- 1. through a method comparison
- 2, through a precision study

#### 5. Intended use:

pHoenix Electrolyte Calibration Set for Medica Easylyte Calcium analyzer is intended to calibrate Na, K, Ca*, pH electrodes of Medica Easylyte Calcium analyzer.

Date: 11/5/01

Signature:

Ram Nunna

President,

pHoenix Diagnostics Inc.

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### Substantial Equivalence Comparison

Standard A and Standard B for Medica EasyLyte Calcium Analyzer Predicate Device Name: K943091 510 (k) Number:

The pHoenix products under application are similar in composition and function to the Medica products as follow I ne products under application as similar in belige and pHoenix products is as follows:

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| Areas | Comparison of<br>pHoenix and<br>Medica products | Comments |
|--------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | | |
| Intended use | Similar | Both are intended for the calibration of<br>Na, K, Ca and pH for the Medica<br>EasyLyte Calcium Analyzer |
| Target population | Similar | Medica EasyLyte Calcium Analyzer |
| Design and material | Similar | Contains Sodium, Potassium, Calcium<br>and buffers in an aqueous base |
| Performance | Similar | See 510(k) Summary |
| Sterility | Similar | No Growth |
| Biocompatibility | Similar | Not Applicable |
| Mechanical Safety | Similar | Not Applicable |
| Chemical Safety | Similar | Both contains no hazardous chemicals |
| Human Factors | Similar | Not Applicable |
| Energy used | Similar | Not Applicable |
| Compatibility with<br>environment and other<br>devices | Similar | Not Applicable |
| Where use? | Similar | Laboratories |
| Standards | Similar | No known standards |
| Electrical, thermal and<br>radiation safety | Similar | Not Applicable |

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 0 7 2001

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

Re: k012987

Trade/Device Name: pHoenix Electrolyte Calibration Set for the Medica EasyLyte Calcium Analyzer Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: September 6, 2001 Received: September 6, 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 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/dsma/dsmamain.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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KD12987

NOV 0 7 2001

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_O 1 2 9 8 7

Device Name: pHoenix Electrolyte Calibration Set for the Medica EasyLyte Calcium Analyzer

Indications For Use:

Intended Use:

The pHoenix Electrolyte Calibrator Set for the Medica EasyLyte Calcium Analyzer is intended for use as The procedes to calibrate Nat, K+, Ca* and pH for the Medica EasyLyte Calcium Analyzer.

(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)

Cooper

(Division Sign-Off)
Division of Cined Labor
510(k) Numbc, KOL2987