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K Number
K984384
Device Name
6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497
Manufacturer
THERMO BIOANALYSIS CORP.
Date Cleared
1998-12-23

(15 days)

Product Code
CHL
Regulation Number
862.1120
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
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. 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.
More Information

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No
The device is a set of calibration reagents and wash solutions for a blood gas analyzer. The description focuses on the chemical composition and intended use for calibration and cleaning, with no mention of AI or ML technologies.

No.
The device is intended for in vitro diagnostic use, specifically for calibrating electrodes and flushing the sample flow path of blood gas analyzers, which are used to measure analytes in blood samples. It does not directly treat or diagnose a patient.

No

The device (ALKO products) is stated to be for "in vitro diagnostic use" and is intended for calibrating electrodes and flushing the sample flow path of a pH/Blood Gas Analyzer. These are reagents used with a diagnostic device (the analyzer), not a diagnostic device itself.

No

The device description clearly states the products are "In Vitro Diagnostic Solutions" and "Reagents," which are physical substances used in laboratory tests, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The products encompassed by this request are intended for in vitro diagnostic use..."
  • Function: The products (Buffer Solutions and Wash Solution) are used to calibrate and maintain a pH/Blood Gas Analyzer, which is a device used to perform in vitro diagnostic tests on blood samples.
  • Classification: The "Device Description" section states the products are "Class II (75JIX) In Vitro Diagnostic Solutions".
  • Purpose: The reagents are used to ensure the accuracy of measurements (pH) taken by the analyzer on patient samples, which is a core function of an IVD.

Therefore, based on the provided text, the device is definitively an In Vitro Diagnostic.

N/A

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

CHL

Device Description

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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.

0

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:

1

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 1NMeanSTDCV%
pHTotal407.1660.00250.0351
W-Run207.1660.00170.0231
pCO2Total4079.31.23431.5574
W-Run2079.31.11771.4103
pO2Total4057.61.54652.6843
W-Run2057.61.32942.3064
Level 2
NMeanSTDCV%
pHTotal407.4310.00190.0262
W-Run207.4310.00130.0170
pCO2Total4043.70.49891.1409
W-Run2043.70.44611.0202
pO2Total4096.21.16321.2089
W-Run2096.20.78570.8165
Level3
----------
NMeanSTDCV%
pHTotal407.6530.00300.0394
W-Run207.6530.00120.0159
pCO2Total4018.90.18560.9811
W-Run2018.90.12940.6841
pO2Total40149.32.86491.9183
W-Run20149.31.55021.0380

Note: \W-Run = Within Run

Page 12 of Page 53

2

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
pH = = = = = =1200.99490.03820.99396.946 - 7.962
pCO2 program1200.99680.13420.99319.3 - 101.8
PO2 - 13:14
CHASTERNE1200.99770.06080.99832.4 - 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.

4

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

5

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)Veronica D. Caluin for AWM
Division of Clinical Laboratory Devices
510(k) NumberK984384
Prescription Use✓ (Per 21 CFR 801.109)OROver-The-Counter Use(Optional Format 1-2-96)
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