(60 days)
R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the linearity of automated hematology analyzers for reticulocyte parameter determinations.
R&D RET-LINE is a multi-level suspension of human erythrocytes and mammalian erythrocytes suspended in a simulated plasma fluid with preservatives packaged in a glass vial with a silicon rubber closure containing 3.0 mL of reagent.
The provided text describes the 510(k) summary for the R&D RET-LINE kit, a hematology quality control mixture, and its nonclinical testing. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within assay ranges over product life | Passed: R&D RET-LINE remained within assay ranges over the life of the product. |
| Meeting linearity specifications | Passed: R&D RET-LINE met linearity specifications. |
| Expiration dating (closed vial) | Established at 75 days (closed vial) when stored at 2 - 8 °C. |
| Open vial stability | No open vial stability claim (intended for single use and discard). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Nonclinical testing of three validation lots" was conducted. The specific number of individual samples or measurements within those lots is not detailed.
- Data Provenance: The data is from "nonclinical testing" performed by R&D Systems, Inc. There is no information regarding the country of origin of the data beyond the manufacturer's location in Minneapolis, MN, USA. The testing is implied to be prospective for product validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study focuses on the performance of a linearity control, and the "ground truth" for such a device is typically established by the manufacturer through rigorous characterization of the control material itself, rather than expert interpretation of patient samples.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided in the document. The testing describes the performance of a quality control material against pre-defined specifications (assay ranges, linearity), not a diagnostic device requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices whose performance depends on human interpretation, which is not the case for a linearity control.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable in the context of this device. The R&D RET-LINE is a physical control material used to assess the linearity of automated hematology analyzers, not an algorithm or software. The "standalone" performance refers to the control material's inherent stability and linearity characteristics when measured by the target hematology analyzers.
7. The Type of Ground Truth Used
- The "ground truth" for this device is the inherent characteristics of the control material itself, specifically its stability (remaining within assay ranges) and linearity. These are established by the manufacturer through laboratory assays and characterization of the material. It's not based on expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. This device is a quality control material, not an AI or machine learning algorithm that requires a "training set." The described testing is for validation of the control material itself.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable. As mentioned above, there is no "training set" for this type of device. The ground truth (stability and linearity) for the control material is established through internal scientific and manufacturing processes by the device manufacturer.
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JAN 2 2 2002
510(k) Summary R&D Systems, Inc. RET-LINE
| Date of Summary: | December 13, 2001 |
|---|---|
| Company Name: | R&D Systems, Inc.614 McKinley Place N.E.Minneapolis, MN 55413 |
| Contact name: | Ralph E. Hogancamp612-656-4413, FAX 612-379-6809 |
| Classification name: | Hematology quality control mixture |
| Product name: | R&D RET-LINE |
| CFR section: | 864.8625 Hematology quality control mixture |
Device Class:
Predicate Device: Retic Chex Linearity, manufactured by Streck Laboratories, 14306 Industrial Rd. Omaha, NE 68144. 510(k) number: K000115
Class II
Description: R&D RET-LINE is a multi-level suspension of human erythrocytes and mammalian erythrocytes suspended in a simulated plasma fluid with preservatives packaged in a glass vial with a silicon rubber closure containing 3.0 mL of reagent.
Intended use: R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the linearity of automated hematology analyzers for reticulocyte parameter determinations.
Comparison with Predicate Device: R&D RET-LINE and Retic Chex Linearity are multi-level devices intended for verification of reticulocyte analysis on a variety of automated hematology instruments. Both contain stabilized human red blood cells and simulated human reticulocytes that properly mimic human whole blood on the intended use analyzers. Both cover a range of reticulocyte percentages that model reportable patient ranges and both comprise a true linearity and can be used to verify the linear operation of the intended hematology analyzers.
Discussion: Nonclinical testing of three validation lots focused on the performance attributes of stability and linearity assessment. R&D RET-LIN passed the acceptance criteria of remaining within the assay ranges over the life of the product. R&D RET-LINE also met linearity specifications. Expiration dating has been established at 75 days (closed vial) when stored at 2 - 8 °C and handled according to instructions for use. Normal use of this product is to use it once and discard any leftover product, therefore, is no open vial stability claim.
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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 & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ralph E. Hogancamp Quality Specialist R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413
Re: K013898
Trade/Device Name: R&D RET-LINE Kit Regulation Number: 21 CFR § 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: January 10, 2002 Received: January 11, 2002
Dear Mr. 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.
JAN 2 2 2002
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Device Name: R&D RET-LINE Kit
Indications for Use:
R&D RET-LINE Kit is a multi-level linearity control that provides a means of measuring the IteeD 1011 Direct is a matology analyzers for reticulocyte parameter determinations.
Josephine Bautista
n S n SyrFord Laboratory Devices 013898 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
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OR
Over-The-CounterUse__
(Optional Format 1-2-96)
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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.