CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO

K981795 · Thermo Bioanalysis Corp. · JIX · Jun 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981795
• Device Name: CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO
• Applicant: Thermo Bioanalysis Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and cleaning / flushing the sample flow path of the equivalent ABL™ pH/Blood Gas Systems. Radiometer Medical/Copenhagen is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. These Reagents are intended to be used with equivalent ABL™ pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Radiometer Medical/Copenhagen. The Calibration Solution, pH 7.4/ 3 and Calibration Solution, pH 6.8/ 4 are intended to provide calibration points for the pH electrode on the analyzer. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode during calibration and measurement. The Cleaning Solution /1, Rinse Solution /5 and Hypochlorite Solution are intended for maintenance of the analyzers electrodes and sample flow path. The products encompassed are to be handled using normal laboratory precautions.

Device Story

ALKO Reagents serve as direct replacements for Radiometer Medical/Copenhagen reagents used in ABL™ pH/Blood Gas Analyzers. Input: chemical solutions (calibration buffers, salt bridge, cleaning, rinse, hypochlorite) applied to analyzer electrodes and flow paths. Operation: solutions facilitate electrode calibration (pH 7.4/3, pH 6.8/4) and maintenance of the reference electrode junction and sample path. Used in clinical laboratory settings by trained personnel. Output: analyzer-generated blood gas and co-oximetry test results. Benefit: enables continued operation of existing ABL™ analyzers using compatible, equivalent reagents; ensures accurate calibration and system cleanliness for reliable diagnostic testing.

Clinical Evidence

Bench testing only. Precision study: 3 levels of control materials measured 1 run/day for 20 days (n=60 total per analyte). Results showed CV% ranging from 0.02% to 2.31%. Method comparison: 51 blood samples analyzed on two ABL™ 500 analyzers (one with ALKO reagents, one with Radiometer reagents). Linear regression analysis yielded slopes between 0.9961 and 1.0106 and R-squared values > 0.999 for pH, pCO2, and pO2.

Technological Characteristics

In vitro diagnostic chemical solutions. Includes buffered calibration solutions (pH 7.4, 6.8), salt bridge solution, cleaning solution, rinse solution, and hypochlorite solution. Designed for use with glass membrane electrodes in ABL™ pH/Blood Gas Analyzers. No electronic or software components; purely chemical reagents.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to calibrate electrodes and maintain (clean/flush) the sample flow path of Radiometer ABL™ pH/Blood Gas Analyzers.

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

• Radiometer Medical/Copenhagen Reagents (S1565/943-791, S1575/943-792, S4915/943-794, S5345/943-795, S4901/943-793, S5362/943-906)

Submission Summary (Full Text)

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JUN 1 2 1998

K9811795

# 510(k) Summary for ALKO Reagents on ABL™ 50, 500, 510, 520, 600. 610 and 620 pH/ Blood Gas Analyzers

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent ABL™ pH/ Blood Gas Analyzers. Radiometer Medical/Copenhagen is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers.

Information herein will support ALKO's position for the intended use of these products to the equivalent ABL™ pH/ Blood Gas Analyzers. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Radiometer Medical /Copenhagen. The Calibration Solutions, pH 7.4/3 and Calibration Solution, pH 6.8/4 are buffered solutions for calibration of the pH electrode. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode and the sample during calibration and measurement. The Cleaning Solution /S and Hypochlorite olution are all used to clean and rinse the analyzers electrodes, and sample flow path.

- . ALKO product A943-791 (Calibration Solution, pH 7.4/ 3) is equivalent to Radiometer Medical/Copenhagen product S1565 / 943-791 (Calibration Solution, pH 7.4/ 3).
- ALKO Product A943-792 (Calibration Solution, pH 6.8/ 4), is equivalent to Radiometer . Medical/Copenhagen S1575 / 943-792 (Calibration Solution, pH 6.8/ 4).
- ALKO product A943-794 (Salt Bridge Solution /2) is equivalent to Radiometer Medical/Copenhagen product S4915 / 943 -794 (Salt Bridge Solution /2).
- . ALKO product A943-795 (Cleaning Solution /1) is equivalent to Radiometer Medical/Copenhagen product S5345 / 943 -795 (Cleaning Solution /1).
- . ALKO product A943-793 (Rinse Solution /5) is equivalent to Radiometer Medical/Copenhagen product S4901 / 943 -793 (Rinse Solution /5).
- . ALKO product A943-906 (Hypochlorite Solution) is equivalent to Radiometer Medical/Copenhagen product S5362 / 943 -906 (Hypochlorite Solution).

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## Page 2 / ALKO 510(k) Summary for ABL™ Equivalent Reagents.

ALKO uses a similar composition, description and packaging design as that used by Radiometer fedical/Copenhagen in its products. Equivalence is explained in the packaging section of this submission. (C.C.) L. Shown performance equivalence of its products to Radiometer Medical/Copenhagen products in the following manner:

- Through a method comparison where results obtained on an equivalent ABL™ p/H Blood Gas O Analyzer, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Radiometer Medical/Copenhagen products; and
- Through a precision study where ALKO products were installed on an equivalent ABL™ p/H O Blood Gas Analyzer and samples were measured one run per day for twenty days. A summary of the results of these studies follows:

## PERFORMANCE CHARACTERISTICS

#### Precision Data

Precision data were collected from the analyses of three levels of control materials measured one run per day for twenty days on an ABL™ 500 pH/pCO2/pO2 analyzer calibrated with all ALKO reagents.

| Analyte | | N | Mean | STD | CV% | Min | Max |
|---------|------------|----|-------|--------|--------|-------|-------|
| pH | Total | 60 | 7.155 | 0.0025 | 0.0344 | 7.149 | 7.159 |
| | Run to Run | 20 | 7.155 | 0.0023 | 0.0325 | 7.149 | 7.157 |
| pCO2 | Total | 60 | 73.5 | 0.8096 | 1.1022 | 72.2 | 75.8 |
| | Run to Run | 20 | 73.5 | 0.7140 | 0.9720 | 72.5 | 75.6 |
| pO2 | Total | 60 | 76.4 | 1.2870 | 1.6848 | 73.9 | 79.2 |
| | Run to Run | 20 | 76.4 | 0.9898 | 1.2951 | 74.8 | 78.7 |

## Level 1

#### Level 2

| Analyte | | N | Mean | STD | CV% | Min | Max |
|---------|------------|----|-------|--------|--------|-------|-------|
| pH | Total | 60 | 7.370 | 0.0022 | 0.0301 | 7.365 | 7.381 |
| | Run to Run | 20 | 7.370 | 0.0015 | 0.0209 | 7.367 | 7.374 |
| pCO2 | Total | 60 | 44.2 | 0.5873 | 1.3296 | 43.4 | 47.5 |
| | Run to Run | 20 | 44.2 | 0.3177 | 0.7193 | 43.8 | 45.1 |
| pO2 | Total | 60 | 102.2 | 1.8308 | 1.7906 | 98.7 | 109.9 |
| | Run to Run | 20 | 102.2 | 1.5290 | 1.4955 | 99.5 | 105.3 |

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Level 3

| Analyte | | N | Mean | STD | CV% | Min | Max |
|---------|------------|----|-------|--------|--------|-------|-------|
| pH | Total | 60 | 7.576 | 0.0026 | 0.0345 | 7.571 | 7.586 |
| | Run to Run | 20 | 7.576 | 0.0020 | 0.0267 | 7.572 | 7.579 |
| pCO2 | Total | 60 | 20.3 | 0.4511 | 2.2171 | 17.4 | 20.8 |
| | Run to Run | 20 | 20.3 | 0.3096 | 1.5214 | 19.2 | 20.8 |
| pO2 | Total | 60 | 157.4 | 3.6420 | 2.3146 | 149.0 | 165.3 |
| | Run to Run | 20 | 157.4 | 3.1385 | 1.9946 | 151.0 | 163.3 |

#### Accuracy by Correlation with Radiometer ABL™ Reagents

Correlation data were obtained from 51 blood samples for pH/pCO2/pO2, measured on two ABL™ 500 analyzers, one calibrated with all ALKO reagents as compared with the other one calibrated with all Radiometer reagents. A Linear Regression Analysis was performed using the Radiometer data as the Independent X Variable and ALKO Data as the Dependent Y Variable in the equation Y = a + bX.

| Analyte | N | Slope | Intercept | R Squared * | Range |
|---------|----|--------|-----------|-------------|---------------|
| pH | 51 | 1.0068 | -0.04888 | 0.9998 | 6.816 - 7.987 |
| CO2 | 51 | 1.0106 | -0.14954 | 0.9995 | 5.1- 152.7 |
| pO2 | 51 | 0.9961 | 0.46989 | 0.9995 | 12.6 - 285.0 |

*R Squared= Correlation Coefficient Squared

I hope you find this information useful and informative.

Jack C. Smith

Janet A, McGrath Regulatory Affairs

## 5|19|98

(date prepared)

(date prepared)

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 2 1998

Janet A. McGrath · Requlatory Affairs Specialist Thermo BioAnalysis 333 Fiske Street Holliston, Massachusetts 01746

Re : K981795 Calibration Solutions pH 7.4, pH 6.8 and Cleaning, Salt Bridge, Rinse and Hypochlorite Solutions Regulatory Class: II Product Code: JIX, CHL May 19, 1998 Dated: Received: May 21, 1998

Dear Ms. McGrath:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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Page 1 of 1

#### 510(k) Number (if known):

## Device Name: Reagents on Equivalent ABL™ pH/Blood Gas Analyzers

#### Indication For Use:

The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and cleaning / flushing the sample flow path of the equivalent ABL™ pH/Blood Gas Systems. Radiometer Medical/Copenhagen is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. These Reagents are intended to be used with equivalent ABL™ pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Radiometer Medical/Copenhagen.

The Calibration Solution, pH 7.4/ 3 and Calibration Solution, pH 6.8/ 4 are intended to provide calibration points for the pH electrode on the analyzer. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode during calibration and measurement. The Cleaning Solution /1, Rinse Solution /5 and Hypochlorite Solution are intended for maintenance of the analyzers electrodes and sample flow path. The products encompassed are to be handled using normal laboratory precautions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory diag
510(k) Number. 282775

Prescription Use *✓*
(Per 21 CFR 801.109)
OR

Over-The-Counter Use *_*_

(Optional Format 1-2-96)