6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497

K984384 · Thermo Bioanalysis Corp. · CHL · Dec 23, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984384
• Device Name: 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
• Applicant: Thermo Bioanalysis Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Dec 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• 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 flushing the sample flow path of the equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzer. Chiron Diagnostics is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The Chiron (Ciba-Corning) pH/Blood Gas Analyzer performs a broad array of blood gas 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 Wash Solution. These Reagents are intended to be used with equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzers. As such. ALKO products are intended to serve as direct replacements to like named products manufactured by Chiron Diagnostics. The Buffer Solution 7.3, and Buffer Solution 6.8, are intended to provide calibration points for the pH electrode on the analyzer. The Wash Solution is intended for rinse of the analyzers sample flow path. The products encompassed are to be handled using normal laboratory precautions.

Device Story

ALKO reagents serve as direct replacements for Chiron Diagnostics reagents used in Chiron (Ciba-Corning) 248 pH/Blood Gas Analyzers. The system utilizes glass membrane electrodes to measure hydrogen ion concentration (pH) in human blood samples. The device consists of 6.8 and 7.3 buffer solutions for electrode calibration and a wash solution for rinsing the analyzer's sample flow path. Operated by laboratory technicians in clinical settings, the reagents maintain the analytical performance of the existing blood gas analyzer. By ensuring accurate calibration and clean flow paths, the reagents support the analyzer's ability to provide reliable blood gas test results, aiding clinicians in patient diagnosis and management.

Clinical Evidence

Bench testing only. Precision study conducted over 5 days (4 runs/day) using 3 levels of control materials (n=40 per level) on a Chiron 248 analyzer. Results showed pH CV% 0.026-0.039, pCO2 CV% 0.98-1.56, and pO2 CV% 1.21-2.68. Method comparison study performed on 120 human blood samples comparing ALKO-calibrated vs. Chiron-calibrated analyzers; correlation coefficients (R^2) were 0.9939 for pH, 0.9931 for pCO2, and 0.9983 for pO2.

Technological Characteristics

In vitro diagnostic chemical reagents (buffers and wash solution). Designed for use with glass membrane electrode-based pH/blood gas analyzers. No electronic or software components; purely chemical/fluidic interface with existing analyzer hardware.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories to calibrate pH electrodes and rinse sample flow paths of Chiron (Ciba-Corning) pH/Blood Gas Analyzers.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• Chiron Diagnostics 6.8 / 7.3 Buffer Pack (K984384)
• Chiron Diagnostics Wash Solution (K984384)

Submission Summary (Full Text)

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K984384

## 510(k) Summary F. 23 10 1 for ALKO Reagents on CHIRON (Ciba-Corning) 248 pH/ Blood Gas Analyzer

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions I he products chooligable of assis Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent Chiron (Ciba-Corning) pH/ Blood Gas Analyzers. Chiron Diagnostics (formally Ciba-Corning) 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 Chiron (Ciba-Corning) pH/ Blood Gas Analyzers. The Chiron (Ciba-Corning) 248 pH/Blood Gas Analyzer performs a broad array of blood gas tests. ALKO manufactures the buffer reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also pri (6.nouther the Wash Solution. The ALKO Reagents are intended to serve as direct replacements to like named oroducts manufactured by Chiron Diagnostics. The Buffer Pack which consists of one bottle each of 6.8 and 7.3 Buffer, are Buffered Solutions for calibration of the pH electrode. The Wash Solution is used to rinse the analyzers sample flow path.

- ALKO product A473-496 (6.8 / 7.3 Buffer Pack) is equivalent to Chiron Diagnostics product 473496 . (6.8 / 7.3 Buffer Pack).
- ALKO Product A473-497 (Wash Solution), is equivalent to Chiron Diagnostics product 473497 . (Wash Solution).

ALKO uses a similar composition and packaging design as that used by Chiron Diagnostics in its products. Equivalence is explained in the packaging section of this submission. ALKO has shown performance equivalence of its products to Chiron Diagnsotics products in the following manner:

- Through a method comparison where results obtained on an equivalent Chiron (Ciba-Corning) O pH Blood Gas Analyzer, calibrated with ALKO products and compared with results obtained on the same analyzer calibrated with Chiron Diagnostics products; and
- Through a precision study where ALKO products were installed on an equivalent Chiron (Ciba-O Corning) pH Blood Gas Analyzer and samples were measured four runs per day for five days. A summary of the results of these studies follows:

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# PERFORMANCE CHARACTERISTICS

### Precision Data

Precision data were collected from the analysis of three levels of control materials, measured in duplicate per run, four runs per day for five days on a Chiron 248 pH/blood gas analyzer calibrated with all ALKO reagents. .....

| Level 1 | | N | Mean | STD | CV% |
|---------|-------|----|-------|--------|--------|
| pH | Total | 40 | 7.166 | 0.0025 | 0.0351 |
| | W-Run | 20 | 7.166 | 0.0017 | 0.0231 |
| pCO2 | Total | 40 | 79.3 | 1.2343 | 1.5574 |
| | W-Run | 20 | 79.3 | 1.1177 | 1.4103 |
| pO2 | Total | 40 | 57.6 | 1.5465 | 2.6843 |
| | W-Run | 20 | 57.6 | 1.3294 | 2.3064 |

| Level 2 | | | | | |
|---------|-------|------|-------|--------|--------|
| | N | Mean | STD | CV% | |
| pH | Total | 40 | 7.431 | 0.0019 | 0.0262 |
| | W-Run | 20 | 7.431 | 0.0013 | 0.0170 |
| pCO2 | Total | 40 | 43.7 | 0.4989 | 1.1409 |
| | W-Run | 20 | 43.7 | 0.4461 | 1.0202 |
| pO2 | Total | 40 | 96.2 | 1.1632 | 1.2089 |
| | W-Run | 20 | 96.2 | 0.7857 | 0.8165 |

| Level | 3 |
|-------|---|
|-------|---|

| | | N | Mean | STD | CV% |
|------|-------|----|-------|--------|--------|
| pH | Total | 40 | 7.653 | 0.0030 | 0.0394 |
| | W-Run | 20 | 7.653 | 0.0012 | 0.0159 |
| pCO2 | Total | 40 | 18.9 | 0.1856 | 0.9811 |
| | W-Run | 20 | 18.9 | 0.1294 | 0.6841 |
| pO2 | Total | 40 | 149.3 | 2.8649 | 1.9183 |
| | W-Run | 20 | 149.3 | 1.5502 | 1.0380 |

Note: \W-Run = Within Run

**Page** 12 **of Page** 53

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# Page 3 / ALKO 510(k) Summary for Chiron (Ciba-Corning) Equivalent Reagents.

#### orrelation with Chiron reagents

- Correlation data were obtained from 120 human blood samples for pH, pCO2 and pO2, measured on two Chiron 248 analyzers; one calibrated with all ALKO reagents as compared with all Chiron reagents. Linear andiyzels, the callirated with an ALKO reagently and ALKO data as the Dependent Y variable in the equation Y=a+ bX.

| | | | Interce | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------|---------|--------|---------------|
| 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000<br>pH = = = = = = | 120 | 0.9949 | 0.0382 | 0.9939 | 6.946 - 7.962 |
| pCO2 program | 120 | 0.9968 | 0.1342 | 0.9931 | 9.3 - 101.8 |
| PO2 - 13:14<br>CHASTERNE | 120 | 0.9977 | 0.0608 | 0.9983 | 2.4 - 293.1 |

Note: R Sq. = Correlation Coefficient squared

I hope you find this information useful and informative.

Janet A. Smith

|2|3|08|
(date prepared)

Hanet A, McGrath Regulatory Affairs

**Page** 13 **of Page** 53

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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract eagle design, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular pattern around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 1998

Janet A. McGrath Regulatory Affairs Specialist Thermo BioAnalysis 333 Fiske Street Holliston, MA 01746

Re: K984384 Trade Name: 6.8/7.8 Buffer Pack & Wash Solution Pack Requlatory Class: II Product Code: CHL Dated: December 4, 1998 December 8, 1998 Received:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. this response to your premarket notification Please note: 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 requlations.

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

# Device Name: Reagents on Equivalent Chiron (Ciba-Corning) 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 flushing the sample flow path of the equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzer. Chiron Diagnostics is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The Chiron (Ciba-Corning) pH/Blood Gas Analyzer performs a broad array of blood gas 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 Wash Solution. These Reagents are intended to be used with equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzers. As such. ALKO products are intended to serve as direct replacements to like named products manufactured by Chiron Diagnostics.

The Buffer Solution 7.3, and Buffer Solution 6.8, are intended to provide calibration points for the pH electrode on the analyzer. The Wash Solution is intended for rinse of the analyzers sample flow path. The products encompassed are to be handled using normal laboratory precautions.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------|
| (Division Sign-Off) | Veronica D. Caluin for AWM |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984384 |

| Prescription Use | <div> <span style="text-decoration: underline;"></span> <span style="margin-left: 5px;">✓</span> </div> (Per 21 CFR 801.109) | OR | Over-The-Counter Use | <span style="text-decoration: underline;"></span> (Optional Format 1-2-96) |
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