Liquichek Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology Instruments that provide a white blood cell differential.

Device Description

Liquichek Hematology Control (A) is a suspension of stabilized human white colls, simulated Liquichek Hernalorogy Continer (A) is a suspention of cells. This product onnains soluble human plateles of animal ongin, and lifestablity of the cellular components. This product is provided in liquid form.

AI/ML Overview

Here's an analysis of the provided text regarding the K041457 submission for the Liquichek Hematology Control (A), focusing on acceptance criteria and supporting studies:

This submission is for a medical device that serves as a quality control mixture for hematology instruments. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel clinical benefit or diagnostic accuracy in humans. Therefore, the "acceptance criteria" and "study" are interpreted in the context of stability and performance within a laboratory setting for quality control.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through stability studies. The reported performance directly addresses these stability claims.

Acceptance Criteria	Reported Device Performance (Summary of Study Results)
Open Vial Stability	All analytes are stable for 7 days when stored at 2 to 8°C.
Shelf Life	60 days when stored at 2 to 8°C.

Note: The document states that "All supporting data is retained on file at Bio-Rad Laboratories." This implies that the detailed results backing these claims are available but not explicitly presented in this summary document. The "performance claims were established using the Abbott Cell-Dyn 3000," which is the instrument used to test the control's stability for the specified analytes.

Detailed Information Regarding the Study:

Given that this is a quality control device submission, many of the typical clinical study parameters (like human patient sample sizes, expert qualifications for ground truth, MRMC studies) are not applicable. The study conducted here focuses on the stability and performance of the control solution itself.

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated in the provided summary. The stability studies would involve multiple units/vials of the Liquichek Hematology Control (A) tested at various time points over 7 days (open vial) and 60 days (shelf life). The instrument used was the Abbott Cell-Dyn 3000.
- Data Provenance: Not explicitly stated beyond Bio-Rad Laboratories, Irvine, California (the submitter). Given it's a control manufactured by Bio-Rad, the studies likely originate from their internal testing facilities. It is a prospective study as it involved testing the stability of the manufactured control over time.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable directly. For a quality control material, the "ground truth" would be the known or assigned values for each analyte in the control solution. This is established through rigorous internal testing and calibration by the manufacturer, rather than by human expert interpretation for individual cases. The "experts" in this context would be the laboratory personnel and scientists involved in the formulation, characterization, and testing of the control material.
Adjudication Method for the Test Set:
- Not applicable. Adjudication typically refers to resolving discrepancies among human readers or interpretations of diagnostic results. For a quality control device's stability study, the performance is measured against predefined analytical specifications or established target values, and any deviations would be handled through standard laboratory quality control processes, not through expert adjudication in the medical diagnostic sense.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is relevant for comparing the diagnostic accuracy of a device (often image-based or involving human interpretation) with and without AI assistance across multiple readers and cases. This device is a diagnostic control, not a diagnostic device that humans interpret.
If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done:
- Yes, effectively. The "study" for this device involved testing the stability of the control solution on a hematology analyzer (Abbott Cell-Dyn 3000). This is essentially a standalone performance evaluation of the control material, as it does not involve human interpretation of its results for diagnostic purposes. The instrument reads the control, and its values are compared against expected ranges.
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for a quality control material is its assigned value or target range for each analyte. These values are established by the manufacturer (Bio-Rad Laboratories) through extensive characterization and calibration using reference methods and/or validated master lot values. It is based on analytical measurements and metrological traceability, not expert consensus on individual cases.
The Sample Size for the Training Set:
- Not applicable. This device is a quality control material and is not an AI algorithm or a diagnostic device that requires a "training set" in the machine learning sense. Its performance is characterized through direct analytical testing for stability and equivalence to a predicate.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As stated above, there is no "training set" in the context of this device. The ground truth for the control material itself (its assigned values) is established through manufacturing and assay processes by Bio-Rad Laboratories.

Summary

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K041457

Summary of Safety and Effectiveness Liguichek Hematology Control (A)

1.0 Submitter

JUN 2 8 2004

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:

Contact Person

Maria Zeballos Requiatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

May 28, 2004

Device Identification 2.0

Product Trade Name:	Liquichek Hematology Control (A)
Common Name:	Hematology and Pathology Devices(Hematology quality control mixture)
Classifications:	Class II
Product Code:	JPK
Regulation Number:	21 CFR 864.8625

Device to Which Substantial Equivalence is Claimed 3.0

Tri-Count 20 Hematology Whole Blood Control Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Plano, Texas 75074

510 (k) Number: K960471

Description of Device 4.0

Intended Use 5.0

Liquichek Hematology Control (A) is an assayed whole blood control for evaluating Liquichek Hematology Oonaor (rt) 16- an accurity blood cell differential.

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6.0 Comparison of the new device with the Predicate Device

Liquichek Hematology Control (A) claims substantial equivalence to the Tri-Count 20 Hematology Whole Blood Control currently in commercial distribution (K960471).

Table 1. Similarities and Differences between new and prodicate device.

Characteristics	Bio-RadLiquichek™ Hematology Control (A)(New Device)	Bio-Rad Laboratories(formerly known as Hematronix, Inc.)Tri-Count 20 Hematology Whole Blood Control(Predicate Device K942295)
Similarities
Intended Use	Liquichek Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology instruments that provide a white blood cell differential	TRI-COUNT 20 is a hematology reference control used in monitoring determination of blood cell values on COULTER STKS, MAXM and other analyzers.
Form	Liquid	Liquid
Matrix	Human Whole Blood based	Human Whole Blood based
Preservatives	Contains preservatives	Contains preservatives
Storage (Unopened)	2°C to 8°CUntil expiration date	2°C to 8°CUntil expiration date
Differences
Open Vial Claim	7 days at 2 to 8°C	14 days at 2°C to 8°C
Analytes	Contain the following parameters same as the predicate:BASO (Basophils)EOS (Eosinophils)HCT (Hematocrit)HGB (Hemoglobin)LYMPH (Lymphocytes)MCH (Mean Corpuscular Hemoglobin)MCHC (Mean Corpuscular Hemoglobin Concentration )MCV (Mean Corpuscular Volume)MID/MONO (Monocytes Mid-Sized Cells)MPV (Mean Platelet Volume)NEU (Neutrophils)PLT (Platelets)RBC (Red Blood Cells)RDW (Red Blood Cell Distribution Width)GRAN (Granulocytes)Does not contain the following parameters:• PDW (Platelet Distribution Width)• PCT (Platelecrit)	Contain the following parameters:BASO (Basophils)EOS (Eosinophils)HCT (Hematocrit)HGB (Hemoglobin)LYMPH (Lymphocytes)MCH (Mean Corpuscular Hemoglobin)MCHC (Mean Corpuscular Hemoglobin Concentration)MCV (Mean Corpuscular Volume)MONO (Monocytes)MPV (Mean Platelet Volume)NEUT (Neutrophils)PLT (Platelets)RBC (Red Blood Cells)RDW (Red Blood Cell Distribution Width)PDW (Platelet Distribution Width)PCT (Platelecrit)Does not contain the following parameters:GRAN (Granulocytes)MID (Mid-Sized Cells)

Statement of Supporting Data 7.0

Stability studies have been performed to determine the open vial stability and shelf life for Stablify studies have been performed to estoluct claims are as follows:

Open vial: All analytes will be stable for 7 days when stored at 2 to 8°C. 7.1
Shelf Life: 60 days at 2 to 8°C. 7.2

All supporting data is retained on file at Bio-Rad Laboratories.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

JUN 2 8 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Manager/ Quality Assurance Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine. CA 92618

K041457 Re:

Trade/Device Name: Hematology Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: Class II Product Code: JPK Dated: May 28, 2004 Received: June 1, 2004

Dear Ms. Platt:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

S. Antman

Robert I.. Becker, Jr., MD, Ph.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K041457
Device Name:	Liquichek Hematology Control (A)
Indications For Use:	Liquichek Hematology Control (A) is an assayed whole blood control for evaluating precision of hematology Instruments that provide a white blood cell differential.
	The following parameters are listed in the package insert:
• BASO (Basophils)	• MCV (Mean Corpuscular Volume)	• RDW (Red Cell Distribution Width)
• EOS (Eosinophils)	• MCHC (Mean Corpuscular Hemoglobin Concentration )	• RBC (Red Blood Cells)
• GRAN (Granulocytes)	• MCH ( Mean Corpuscular Hemoglobin)	• WBC (White Blood Cells)
• HGB (Hemoglobin)	• MONO/MID (Monocytes/Mid-Sized Cells)	- NOC (Nucleated Optical Count)
• HCT (Hematocrit)	• NEU (Neutrophils)	- WIC (White Impedance Count)
• LYMPH (Lymphocytes)	• PLT (Platelets)	- WOC (White Optical Count)

• MPV (Mean Plateiet Voluma)

Performance claims were established using the Abbott Cell-Dyn 3000.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Joachin-Rantala

Office of In Vitro Diagnostic Device Evaluanon and Safe

510(k) K041452

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 864.8625 Hematology quality control mixture.

(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.