A reformulated reagent used to measure hemoglobin without the use of potassium cyanide.
A special cap and straw for the reagent bottle that restricts air exchange with the reagent.
A modified colorimeter that measures the hemoglobin reaction at 565 nm.
Modified software to implement the algorithms necessary to calculate hemoglobin concentration when using the optional reagent and hardware for the method.

AI/ML Overview

The provided text describes the ADVIA 120 Cn-free Hgb Method, a cyanide-free hemoglobin determination option for a hematology analyzer, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific quantitative acceptance criteria or detailed numerical performance data. Instead, it states that the new method is "Equivalent to predicate method" for several performance characteristics.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy	Equivalent to predicate method	Equivalent to predicate method
Precision	Equivalent to predicate method	Equivalent to predicate method
Linearity	Equivalent to predicate method	Equivalent to predicate method
Carryover	Equivalent to predicate method	Equivalent to predicate method

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The test results included in this submission demonstrate that the ADVIA 120 Cn-free Hgb Method has equivalent accuracy, precision, linearity, and carryover similar to the ADVIA 120 predicate method."

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a quantitative measurement instrument. The "ground truth" would typically refer to a reference method or a highly accurate established measurement of hemoglobin concentration, rather than expert judgment.

4. Adjudication Method for the Test Set

Not applicable, as this involves objective quantitative measurements and comparison to a predicate device/reference method, not subjective expert assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic aids where multiple human readers interpret cases with and without AI assistance. This device is an automated quantitative analyzer.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, the study described is a standalone performance assessment of the ADVIA 120 Cn-free Hgb Method. It evaluates the device's ability to measure hemoglobin concentration without human intervention in the measurement process, against the performance of a predicate device.

7. The Type of Ground Truth Used

The "ground truth" for this type of device would implicitly be the results obtained by the ADVIA 120 cyanide containing Hgb predicate method (K971998) and/or other established, accurate reference methods for hemoglobin measurement. The study aimed to demonstrate equivalence to this predicate.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing analytical instrument and its reagents, not a machine learning algorithm that requires a "training set" in the conventional sense. The "modified software to implement the algorithms" likely refers to analytical algorithms, not machine learning algorithms trained on large datasets.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for a machine learning algorithm.

Summary

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K012904

510(k) Summary of Safety and Effectiveness

SEP 2 1 2001 510(k) Summary of Safety and Effectiveness

The following information provides data supporting a substantially equivalent determination between the ADVIA 120 Cn-free Hqb Method and the ADVIA 120 cyanide containing Hgb predicate method (K971998).

Intended Use

The ADVIA 120 Cn-free Hgb Method is intended to provide an in vitro diagnostic, quantitative measurement of hemoglobin concentration in a sample of whole blood.

Device Description

The ADVIA 120 Cn-free Hgb Method consists of the following optional changes to the ADVIA 120 Hematology System:

1. A reformulated reagent used to measure hemoglobin without the use of potassium cyanide.
1. A special cap and straw for the reagent bottle that restricts air exchange with the reagent.
1. A modified colorimeter that measures the hemoglobin reaction at 565 nm.
1. Modified software to implement the algorithms necessary to calculate hemoglobin concentration when using the optional reagent and hardware for the method.

Principles of Operation

When using the ADVIA 120 Cn-free Hgb Method, the blood sample is diluted 1:250 with diluent. The dilyent contains an ionic surfactant which is dissolved in NaOH. The surfactant causes hemolysis of red cells, plus emulsification of cellular debris and plasma lipids. Following the release of hemoglobin by hemolysis, the combined action of alkaline pH and surfactant results in rapid denaturation of the protein with release of the hemes. The hemes then undergo air oxidation of heme iron to the iron III state and coordinate one hydroxide ion and one water molecule as axial ligands to form monoaquomonohydroxyiron III-porphyrin. The diaxial-coordinated hemes are then incorporated into surfactant micelles to yield the reaction product. Absorbance is measured at approximately 565 nm in a colorimeter flow cuvette, with an 8-mm light path.

Similarities and Differences between the ADVIA 120 Cn-free Hgb Method and the ADVIA 120 Cyanide Containing Hgb Predicate Method (K971998)

The following table provides similarities and differences between the ADVIA 120 Cnfree Hgb Method and the ADVIA 120 cyanide containing predicate method.

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		ADVIA 120 Cyanide	ADVIA 120
Similarities/Differences	Characteristic	Containing Method	Cn-free Method
Similarities	Intended Use	To provide a quantitativemeasurement ofhemoglobin concentrationin whole blood.	Same as predicatemethod.
	Calibrator Material	ADVIA SETpointCalibrator	Same as predicatemethod.
	Quality Control Materials	ADVIA TESTpointHematology Controls	Same as predicatemethod.
	Accuracy	As specified in productlabeling.	Equivalent to predicatemethod.
	Precision	As specified in productlabeling.	Equivalent to predicatemethod.
	Linearity	As specified in productlabeling.	Equivalent to predicatemethod.
	Carryover	As specified in productlabeling.	Equivalent to predicatemethod.
Differences	Reagent and SystemEffluent	Hgb reagent and systemeffluent contain cyanide.	Hgb and systemeffluent do not containcyanide.
	AbsorbanceMeasurement	Measured at 546 nm.	Measured at 565 nm.
	Air Exchange withReagent	No precaution taken.	Restricted airexchange usingspecially designed capand straw for reagentbottle.

Conclusion

The test results included in this submission demonstrate that the ADVIA 120 Cn-free Hgb Method has equivalent accuracy, precision, linearity, and carryover similar to the ADVIA 120 predicate method.

Leweet. Joda

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

Date 8/25/01

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines that resemble a bird's wing or a ribbon.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 1 2001

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

K012904 Re:

Trade/Device Name: Cyanide-Free Hemoglobin Determination Option for the Advia 120 Hematology Analyzer

Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: August 29, 2001 Received: August 29, 2001

Dear Dr. Edds:

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 (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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrlvdsma/dsmamain.html".

Sincerely yours.

Steven Autman

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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K012904 510(k) Number:

Device Name: Cyanide-free Hemoglobin Determination Option for the Advia 120 Hematology Analyzer

Indications for Use: The Advia 120 Cn-free Hgb method is intended to quantitatively measure hemoglobin concentration in a sample of whole blood.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Division of Clinical Laboratory Devices
510(k) Number K012904

Prescription Use ﻟﻤﺴﺎ (Per 21 CFR 801.109)

Over-The-CounterUse

(Optional Format 1-2-96)

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”