PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM

K012509 · Phoenix Diagnostics, Inc. · JIX · Oct 9, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012509
• Device Name: PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
• Applicant: Phoenix Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na+, K+, Cl- and TCO2 for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.

Device Story

pHoenix Electrolyte Calibration Set consists of A, B, and C levels; used to calibrate Na+, K+, Cl-, and TCO2 analytes on Dade/Behring Dimension Chemistry Systems equipped with MultiPLY™ Integrated Multisensor module. Device serves as direct replacement for Alko Diagnostic Corporation calibrators. Used in clinical laboratory settings by laboratory personnel. Calibration ensures accuracy of electrolyte measurements performed by the analyzer's integrated multisensor and ion selective electrode. Benefits include maintaining analytical performance and measurement accuracy for clinical diagnostic testing.

Clinical Evidence

Bench testing only. Performance equivalence demonstrated through method comparison studies and precision studies (20 runs) on the Dade/Behring Dimension Chemistry System with MultiPLY™ Integrated Multisensor module.

Technological Characteristics

In vitro diagnostic calibration solutions (Class II, JIX). Consists of three levels (A, B, C). Designed for use with Dade/Behring Dimension Chemistry Systems. Replaces Alko Diagnostic Corporation calibrators.

Indications for Use

Indicated for use as calibrators for Na+, K+, Cl-, and TCO2 analytes on the Dade/Behring Dimension Chemistry Systems with MultiPLY™ Integrated Multisensor module installed. No specific patient population or contraindications provided.

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

• Alko Diagnostic Corporation calibrators (referenced via K902675)

Submission Summary (Full Text)

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K012509

## OCT - 9 2001

## 510 (k) Summary

pHoenix Electrolyte Calibration Set for the Dade/Behring Dimension® Chemistry Systems with MultiPLYTM Integrated Multisensor module installed

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 an A, B and Clevel and is intended for use in calibrating Nat, K., C." and TCO2 analytes on the Dade/Behring Dimension Chemistry Systems. Dade/Behring Chemistry Systems, Inc. is the original equipment manufacturer (OEM) of the system,

The pHoenix products stated are currently cleared under docker K902675. Information herein will support pHoenix's position to extend the intended use of these products to the Dade Behring Dimension "Chemistry Systems with MultiPLY™ Integrated Multisensor module installed. The MultiPLY™ Integrated Multisensor module measures Nat, K, and Cli by using Integrated Multiple Technology means. The TCO2 analyte is measured by the system's Ion Selective Blectrode. The pHoenix Calibrator Reagents are intended to serve as direct replacements to like named products manufactured by Alko Diagnostic Corporation. PHoenix Product Calibrator A is equivalent to Alko Product A202-0. . pHoenix Product Calibrator B is equivalent to Alko Product A 103-0. . pHoenix Product Calibrator C is equivalent to Alko Product A200-0.

pHoenix uses a similar composition, description and packaging design as that used by Alko Diagnostic Corporation in its products. pHoenix has shown performance equivalence of its products to Alko Diagnostic Corporation products in the following manner:

- Through a method comparison where results obtained on a Dade/Behring Dimension Chemistry Systems . with MultiPLYM Integrated Multisensor module installed, calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Alko products; and
- . Through a precision study where pHoenix products were installed on a Dade/Behring Dimension on Chemistry Systems with MultiPLY™ Integrated Multisensor module installed and samples were measured over 20 runs.

Image /page/0/Picture/9 description: The image shows the text "pHoenix Diagnostics, Inc.". The text is in a bold, sans-serif font. The word "pHoenix" is larger than the rest of the text. The text is black and the background is white.

**RAM NUNNA**
PRESIDENT

8 TECH CIRCLE NATICK MA 01760

TEL: [phone]

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 9 2001

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

Re: k012509

K012507
Trade/Device Name: pHoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension® Chemistry System

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 30, 2001 Received: August 6, 2001

Dear Mr. Nunna:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regard the Medical Device Amendments, or to conninered pror to rias 2017 3) in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmette Tree, market the device, subject to the general controls provisions of the Act. The I ou may, dierelore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classined (500 a00 vy als. Existing major regulations affecting your device can may be subject to back as acceral 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 I lease be actived that I Drivination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or any I could statutes and regisments, including, but not limited to: registration and listing (21 comply with an the rice orequirements (1); good manufacturing practice requirements as set CI It Fat 6077; adoming (Dr CFR Part 820); and if applicable, the electronic rordline and quality by stations (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 [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 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): K 012509.

Device Name: pHoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension_ Chemistry System

Indications For Use:

Intended Use:

The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na ", K ", CI and TCO2 for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.

(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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. H012509