(22 days)
R&D LH-nRBC Hematology Control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.
This control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods.
Here's an analysis of the provided text regarding the R&D LH-nRBC Hematology Control, formatted to address your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product. | "R&D LH-nRBC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Precision (indicated by standard deviation and % CV's) | "R&D LH-nRBC Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing." |
| Closed Vial Stability | "Expiriation dating has been established at 75 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use." |
| Open Vial Stability | "Expiriation dating has been established at... 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use." |
| Substantial Equivalence to Predicate Device | "Laboratory testing of 3 validation lots has shown R&D LH-nRBC Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Laboratory testing of 3 validation lots." However, it does not explicitly state the specific sample size (e.g., number of test runs, number of instruments, or number of individual control vials/measurements) for each lot.
The data provenance is not explicitly stated in terms of country of origin. The study was conducted by R&D Systems, Inc., which is located in Minneapolis, MN, USA. The nature of the study (retrospective or prospective) is not specified, but the description of "laboratory testing of 3 validation lots" suggests a controlled, prospective study designed for validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for this type of device (a quality control mixture) is typically established by the inherent properties of the control material and its performance on standardized instruments, rather than human expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods are typically used when human interpretation is involved in establishing ground truth, such as in image analysis or clinical diagnosis studies. For a hematology control, "acceptance criteria" are quantitative and directly measured by instruments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, where the goal is to assess how a device affects human reader performance. This device is a quality control material for instruments, not a diagnostic device for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence, a standalone performance assessment was done. The "device" in this context is the control mixture itself, which is designed to perform consistently on automated hematology instruments. The testing described focuses on the control's intrinsic performance (stability, precision, staying within assay range) when run on these instruments, without human interpretive input altering the results being assessed. The phrase "laboratory testing of 3 validation lots" and the reporting of "small standard deviation and % CV's" directly reflect the standalone performance of the control.
7. The Type of Ground Truth Used
The ground truth for this device is based on pre-defined assay ranges and established precision metrics for hematology instruments. The control is designed to produce expected values within these ranges and with acceptable precision. The "ground truth" is not derived from expert consensus, pathology, or outcomes data in the usual diagnostic sense, but rather from the known performance characteristics required for a reliable quality control product.
8. The Sample Size for the Training Set
This information is not provided and is largely not applicable in the conventional sense for this type of device. A quality control material like this does not typically have a "training set" in the way an AI algorithm would. Its formulation and expected performance are established through chemical and biological engineering, and then validated through testing. There might have been R&D formulation studies or preliminary testing, but these aren't described as a "training set" in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and its associated ground truth is not explicitly applicable or described for this device. The "ground truth" for the control's design and intended performance would have been established through a combination of:
- Manufacturer specifications: The R&D team designing the control would define what constitutes "in range" and "precise" performance based on the requirements of the hematology instruments it's intended to monitor.
- Instrument manufacturer's specifications: The control is designed for "Coulter® hematology instruments," so the performance characteristics and acceptable variations of these instruments would inform the control's ground truth.
- Industry standards: General good manufacturing practices and standards for quality control materials for IVD devices would guide establishment of acceptable performance.
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JUN - 2 2006
Lo61320
510(k) Special Summary R&D Systems, Inc. LH-nRBC Hematology Control
| Date of Summary: | May 10, 2006 |
|---|---|
| Company Name: | R&D Systems, Inc.614 McKinley Place N.E.Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp612-656-4413, FAX 612-379-6580 |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D LH-nRBC Hematology Control |
| CFR section: | 864.8625 Hematology quality controlmixture. |
| Device Class: | Class II |
Predicate Device: R&D Systems CBC-5D Hematology Control, K983032 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413
Description: This control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods.
Intended use: R&D LH-nRBC Hematology Control is a tri-level control for useain monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.
Comparison: Both products are used to monitor Coulter® multi-parameter hematology instruments. The R&D LH-nRBC added new parameters.
Discussion: Laboratory testing of 3 validation lots has shown R&D LH-nRBC Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D LH-nRBC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D LH-nRBC Hematology Control has demonstrated precision as indicated by the small standard deviation and % CV's obtained during laboratory testing. Expiriation dating has been established at 75 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructons for use.
Conclusion: R&D LH-nRBC Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ralph E. Hogancamp Regulatory Affairs R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
JUN - 2 2006
Re: K061320 Trade/Device Name: R&D LH-nRBC Hematology Control Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: II Product Code: JPK Dated: May 10, 2006 Received: May 16, 2006
Dear Hogancamp:
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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PK 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): K 00/ 320
Device Name: R&D LH-nRBC Hematology Control
Indications for Use:
R&D LH-nRBC Hematology Control is a tri-level control for use in monitoring the performance of Coulter® hematology instruments and other auxiliary methods. Refer to assay sheet for specific instrument models.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE TO USE ANOTHER PAGE IF NEEDED)
Josephine Bautista
Division Sign=0
Office of In Vitro Diagnostic Device Evaluation and Safety
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K061320 :10(k) _______________________________________________________________________________________________________________________________________________________________________
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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.