Liquichek Hematology-16 Control LV is intended for use as an assayed hematology control to monitor the precision of hematology analyzers that measure the following parameters: GRAN (Granulocytes), HCT (Hematocrit), HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), MCV (Mean Corpuscular Volume), MID (Mid-Sized Cells), MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), WBC (White Blood Cells).

Device Description

This product is a suspension of stabilized lysable human erythrocytes, simulated platelet components, simulated white cells and constituents of animal origin in a medium containing stabilizers and preservatives.

AI/ML Overview

The provided text describes a medical device, the Bio-Rad Laboratories Liquichek Hematology-16 Control LV, and its submission for 510(k) premarket notification. The document focuses on establishing substantial equivalence to a predicate device and includes stability data.

Here's an analysis of the acceptance criteria and the study as requested:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be primarily related to its stability and performance as a quality control material, specifically its ability to maintain its assayed values over time. The document highlights two key stability claims:

Acceptance Criteria	Reported Device Performance
Open vial Stability	All analytes stable for 21 days at 2 to 8°C.
Shelf Life Stability	160 days at 2-8°C.

Study Details:

Sample size used for the test set and the data provenance:
The document states that "Stability studies have been performed to determine the open vial stability and shelf life for this control." However, it does not specify the exact sample size (number of vials, number of runs, etc.) used for these stability studies. The data provenance is internal, as it's from Bio-Rad Laboratories, and the studies were conducted to support the device's claims. It is a prospective study in the sense that the stability was tested for the duration of the claimed shelf life and open-vial stability.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a hematology control, "ground truth" would likely refer to the assayed values of the analytes. These values are typically established through extensive testing on reference instruments, often by qualified laboratory personnel. The document does not detail this process or the qualifications of personnel involved in establishing these true values.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are typically relevant in studies involving subjective interpretation (e.g., image analysis by multiple readers). For a quantitative control like this, the "adjudication" would be through statistical analysis of the measured values over time against established reference ranges or by comparison to highly accurate reference methods. The document does not detail the statistical methods or how deviations were handled.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is a hematology quality control material, not an AI or diagnostic imaging device that involves human readers. Therefore, the concept of human readers improving with AI assistance is not applicable here. The study focuses purely on the stability and performance of the control material itself.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable in the context of an algorithm. This device is a physical control material. However, the stability studies effectively represent a "standalone" assessment of the control material's stability without human intervention affecting its core stability properties. The performance monitored is the stability of the analytes within the control.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a hematology control, the "ground truth" for the analyte values would be the assigned assayed values determined by Bio-Rad Laboratories during the manufacturing and characterization process, likely using established reference methods and calibrated instruments. This is typically analogous to a "reference standard" or "master value" rather than expert consensus, pathology, or outcomes data. The document does not explicitly state the methodology for establishing these initial assayed values.
The sample size for the training set:
This device is a quality control material and does not involve AI or machine learning, therefore, there is no training set in the conventional sense of developing an algorithm. The "training" for such a product would be the formulation and manufacturing process development.
How the ground truth for the training set was established:
As there is no training set for an AI algorithm, this question is not applicable.

Summary

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Bio-Rad Laboratories Liquichek Hematology-16 Control LV Premarket Notification Section 510(k)

1.0 Submitter

Bio-Rad Laboratories 524 Stone Road, Suite A Benicia, California 94510 Telephone: (949) 598-1200 Fax: (949) 598-1557

Contact Person

Suzanne S. Parsons Regulatory Affairs Specialist Telephone: (949) 598-1467

Date of Summary Preparation

July 30, 2010

2.0 Device Identification

Product Name:	Liquichek Hematology-16 Control LV
Common Name:	Hematology and Pathology DevicesHematology quality control mixture
Classification:	Class II
Product Code:	JPK
Regulation Number:	21 CFR 864.8625

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Hematology-16 Control (formerly known as TRI-COUNT 16) Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Benicia, CA 94510

510 (k) Number: K902389

4.0 Description of Device

5.0 Intended Use

K 091303

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MONO (Monocytes), MPV (Mean Platelet Volume), PLT (Platelets), RBC Red Blood Cells), RDW (Red Blood Cell Distribution Width), and WBC (White Blood Cells).

6.0 Comparison of the new device with the Predicate Device

Liquichek Hematology-16 Control LV claims substantial equivalence to the Liquichek Hematology-16 Control currently in commercial distribution (K902389).

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

Characteristics	Bio-RadLaboratoriesLiquichek™ Hematology-16 Control LV(New Device)	Bio-Rad LaboratoriesLiquichek™ Hematology-16 Control(Formerly known as TRI-COUNT 16)(Predicate Device K902389)
Similarities
Intended Use	Liquichek Hematology-16 Control LV is Intended for use asan assayed hematology control to monitor the precision ofhematology analyzers that measure the followingparameters: GRAN (Granulocytes), HCT (Hematocrit),HGB (Hemoglobin), LYMPH (Lymphocytes), MCH (MeanCorpuscular Hemoglobin), MCHC (Mean CorpuscularHemoglobin Concentration), MCV (Mean CorpuscularVolume), MID (Mid-Sized Cells), MONO (Monocytes),MPV (Mean Platelet Volume), PLT (Platelets), RBC RedBlood Cells), RDW (Red Blood Cell Distribution Width),and WBC (White Blood Cells).	Liquichek Hematology 16 Control is a hematology referencecontrol used in monitoring determinations of blood cell valueson cell counters.
Form	Liquid	Liquid
Matrix	suspension contains blood cells	suspension contains blood cells
Preservatives	Contains preservatives	Contains preservatives
Storage (Unopened)	2°C to 8°C	2°C to 8°C
Open Vial Claim	21 days at 2 to 8°C	21 days at 2°C to 8°C
Analytes	Contain the following parametersGRAN (Granulocytes)HCT (Hematocrit)HGB (Hemoglobin)LYMPH (Lymphocytes)MCH (Mean Corpuscular Hemoglobin)MCHC (Mean Corpuscular Hemoglobin Concentration)MCV (Mean Corpuscular Volume)MID (Mid-Sized cells) / MONO (Monocytes)MPV (Mean Platelet Volume)PLT (Platelets)RBC (Red Blood Cells)RDW (Red Blood Cells Distribution Width)WBC (White Blood Cells)	Contain the following parametersGRAN (Granulocytes)HCT (Hematocrit)HGB (Hemoglobin)LYMPH (Lymphocytes)MCH (Mean Corpuscular Hemoglobin)MCHC (Mean Corpuscular Hemoglobin Concentration)MCV (Mean Corpuscular Volume)MID (Mid-Sized cells) / MONO (Monocytes)MPV (Mean Platelet Volume)PLT (Platelets)RBC (Red Blood Cells)RDW (Red Blood Cells Distribution Width)WBC (White Blood Cells)
Differences
Fill Volume	1.5 mL	3.0 mL
Vial Type	Glass vials	Glass tubes with pearceable caps

7.0 STATEMENT OF SUPPORTING DATA

Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:

7.1 Open vial Stability:
All analytes will be stable for 21 days at 2 to 8°C.
7.2 Shelf Life Stability: 160 days at 2-8°C

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8.0 Statement of Supporting Data

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

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Bio-Rad Laboratories Ms. Suzanne Parsons Regulatory Affairs Representative 9500 Jeronimo Road Irvine, California 92618

AUG 0 2 2010

Re: K091303

Trade/Device Name: Liquichek Hematology-16 Control LV Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control Regulatory Class: Class II Product Code: JPK Dated: July 23, 2010 Received: July 26, 2010

Dear Ms. Parsons:

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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Ms. Suzanne Parsons

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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

AUG 0 2 2010

510(k) Number (if known): K 0 9 130 3

Device Name:

Liquichek Hematology-16 Control LV

Indications For Use:

Prescription Use X (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091303

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.