(22 days)
Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.
This is a liquid product composed of stabilized human red blood cells suspended in a buffered fluid with added constituents of animal origin and preservatives.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Rad Laboratories Liquichek Reticulocyte Control (A), formatted to address your specific questions:
Device: Bio-Rad Laboratories Liquichek Reticulocyte Control (A)
Study Purpose: To demonstrate substantial equivalence to a predicate device (Liquichek Reticulocyte Control, K993496) and support product claims for stability.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Open Vial Stability | 21 days at 2°C to 8°C | Claims: 21 days at 2°C to 8°C (supported by stability studies) |
| Shelf Life (Unopened Vial) | 110 days at 2°C to 8°C (Implicit, based on predicate) | Claims: 110 days at 2°C to 8°C (supported by stability studies) |
| Precision of automated methods of reticulocyte counting | "Evaluating precision" (No specific quantitative acceptance criteria are provided in the document for this intended use beyond comparison to the predicate) | Device is intended for "evaluating precision" of automated methods. Substantial equivalence to predicate suggests similar performance. |
Note: The provided document is a 510(k) summary, which focuses on substantial equivalence rather than a full performance study report with detailed quantitative acceptance criteria and results. The "reported device performance" are primarily the claims made based on internal studies.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the stability studies. It only mentions that "Stability studies have been performed..."
The data provenance is internal to Bio-Rad Laboratories, as stated: "All supporting data is retained on file at Bio-Rad Laboratories." This implies the data would be generated within their facilities. The document does not specify country of origin for data or whether it was retrospective or prospective. Given it's a new device, the studies would logically be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided in the context of this 510(k) summary. The device is a quality control material intended to evaluate the precision of automated methods of reticulocyte counting. It is not a diagnostic device that requires expert interpretation to establish a clinical ground truth for a test set of patient samples. The "ground truth" for a control material would be its manufacturing specifications and reference values.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Since the device is a quality control material and not a diagnostic tool requiring interpretation of clinical data, there would be no adjudication of diagnostic results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tools where human readers interpret patient cases, and the AI's impact on their performance is being evaluated. The Liquichek Reticulocyte Control (A) is a quality control material, not a diagnostic AI system with human interpretation involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done because the device is a quality control material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device, a quality control material, would be its established reference values determined through manufacturing processes and validation methodologies. These values ensure the control material performs consistently and within expected ranges, allowing laboratories to assess the precision of their reticulocyte counting instruments. The document does not specify the exact methods for establishing these "truth" values, but they would derive from internal laboratory testing and characterization.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The device is a quality control material, not an AI or algorithm that would require a "training set" of data for machine learning. Its development involves manufacturing processes, formulation, and analytical validation rather than algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided, as there is no "training set" for this type of medical device.
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K042836
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Bio-Rad Laboratories NOV - 5 2004 Liquichek Reticulocyte Control (A) Summary of Safety and Effectiveness
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
October 11, 2004
2.0 Device Identification
| Product Name: | Liquichek Reticulocyte Control (A) |
|---|---|
| Common Name: | Hematology and Pathology DevicesHematology quality control mixture) |
| Classifications: | Class II |
| Product Code: | JPK |
| Regulation Number: | 21 CFR 864.8625 |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Reticulocyte Control Bio-Rad Laboratories (formerly known as Hematronix, Inc.) Benicia, California 94510
510 (k) Number: K993496
4.0 Description of Device
This is a liquid product composed of stabilized human red blood cells suspended in a buffered fluid with added constituents of animal origin and preservatives.
5.0 Intended Use
Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.
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6.0 Comparison of the new device with the Predicate Device
Liquichek Reticulocyte Control (A) claims substantial equivalence to the Liquichek Reticulocyte Control currently in commercial distribution (K993496). Both of these are liquid, whole blood based controls for evaluating precision of reticulocyte counting.
| Characteristics | Bio-Rad LaboratoriesLiquichek™ Reticulocyte Control (A)(New Device) | Bio-Rad Laboratories(formerly known as Hematronix, Inc.)Liquichek Reticulocyte Control(Predicate Device K993496) |
|---|---|---|
| Similarities | ||
| Intended Use | Liquichek Reticulocyte Control (A) is an assayed whole bloodcontrol for evaluating precision of automated methods ofreticulocyte counting. | Liquichek Reticulocyte Control is a whole blood reference controlmaterial designed to verify the precision of COULTERinstruments equipped with reticulocyte measuring capabilitiesusing VCS technology, and New Methylene Blue Stain. |
| Form | Liquid | Liquid |
| Analytes | Reticulocyte | Reticulocyte |
| 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 | 21 days at 2°C to 8 °C | 31 days at 2 to 8°C |
| Table 1. Similarities and Differences between new and predicate device. | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------------------------- |
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek Elevated Immunosuppressant Control. Product claims are as follows:
- . Open vial Stability: 21 days at 2 to 8°C.
- . Shelf Life: 110 days at 2 to 8 °C
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three swooping lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017
NOV - 5 2004
Re: K042836
Trade/Device Name: Liquichek Reticulocyte Control (A) Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: October 11, 2004 Received: October 14, 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). 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.
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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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., 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
510(k) Number (if known):
Device Name:
Liquichek Hematology Control (A)
Indications For Use:
Liquichek Reticulocyte Control (A) is an assayed whole blood control for evaluating precision of automated methods of reticulocyte counting.
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)
Josephine Bautista
Division Sign/Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042836
§ 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.