(455 days)
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No
The document describes a hematology control material used to monitor the precision of hematology analyzers, not a device that performs analysis or incorporates computational algorithms like AI/ML.
No
This device is an assayed hematology control used to monitor the precision of hematology analyzers, not to directly treat or diagnose a disease in a patient.
No
The device is described as an "assayed hematology control" intended to "monitor the precision of hematology analyzers," not to diagnose diseases or conditions directly.
No
The device description clearly states it 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," indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is a "hematology control to monitor the precision of hematology analyzers." This means it is used in vitro (outside the body) to assess the performance of instruments that analyze blood components.
- Device Description: The description details the composition of the product, which is a suspension of biological and simulated components used for testing.
- Performance Studies: The mention of stability studies further supports its use as a diagnostic control.
- Predicate Device: The identification of a predicate device (K902389; Liquichek Hematology-16 Control) which is also a hematology control, indicates that this type of product is regulated as an IVD.
The core function of this device is to be used in vitro to evaluate the accuracy and precision of diagnostic instruments, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
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), and WBC (White Blood Cells).
Product codes
JPK
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.
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)
Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:
- Open vial Stability: All analytes will be stable for 21 days at 2 to 8°C.
- Shelf Life Stability: 160 days at 2-8°C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 Devices |
| Hematology 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
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.
5.0 Intended Use
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),
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-RadLaboratories
Liquichek™ Hematology-16 Control LV
(New Device) | Bio-Rad Laboratories
Liquichek™ Hematology-16 Control
(Formerly known as TRI-COUNT 16)
(Predicate Device K902389) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | 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),
and WBC (White Blood Cells). | Liquichek Hematology 16 Control is a hematology reference
control used in monitoring determinations of blood cell values
on 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 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 Cells Distribution Width)
WBC (White Blood Cells) | Contain 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 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:
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).
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
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