(107 days)
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
For in vitro Diagnostic Use Only.
The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
The provided document describes the R&D 5D Retic Hematology Control, an in vitro diagnostic reagent used to monitor reticulocyte counting methods on Coulter® hematology analyzers. The submission is a 510(k) for substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in performance to predicate device | Laboratory testing of 3 validation lots showed substantial equivalence in performance to the predicate device. |
| Substantial equivalence in precision to predicate device | Laboratory testing of 3 validation lots showed substantial equivalence in precision to the predicate device. |
| Substantial equivalence in stability to predicate device | Laboratory testing of 3 validation lots showed substantial equivalence in stability to the predicate device. |
| Remaining within range over the life of the product | The R&D 5D Retic Hematology Control passed the acceptance criteria of remaining within range over the life of the product. |
| Established expiration dating | Expiration dating will be established at 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructions for use. (This is a result of the stability testing that met the previous criterion). |
Study Details:
The study was a laboratory validation study comparing the R&D 5D Retic Hematology Control to its predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: "3 validation lots" were used. The document does not specify the number of individual vials or measurements within each lot.
- Data Provenance: The study was conducted by R&D Systems, Inc. in Minneapolis, MN, USA. The data would be considered prospective, as it was generated specifically for this 510(k) submission to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This device is a quality control material for hematology analyzers, not a diagnostic imaging or interpretive device that requires human expert opinion for ground truth. The "ground truth" for a quality control material is its expected range of values when tested on specified instruments, which is typically established through extensive internal testing by the manufacturer using validated reference methods and statistical analysis. The document does not mention the involvement of external experts in establishing the ground truth ranges for the control material itself. The performance comparison is against a predicate device, implying that the predicate's established performance serves as a benchmark.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As this is a quality control material, there is no "ground truth" established by human adjudication in the traditional sense of diagnostic assessments. Performance is determined by instrumental readings and statistical comparison to established ranges and predicate device performance.
5. 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
Not applicable. This device is a hematology control, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical control material. The "performance" is its ability to produce expected results on a hematology analyzer, not an algorithm's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a hematology control is its pre-established assayed values and expected ranges for specific parameters (RET%, RET#, IRF, MRV) on designated hematology analyzers. These ranges are determined by the manufacturer through rigorous testing using calibrated instruments and reference methods. The study's aim was to demonstrate that the new control material performs substantially equivalently to the predicate device, meaning its values fall within comparable expected ranges or demonstrate similar precision and stability characteristics.
8. The sample size for the training set
Not applicable. This is a quality control material, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no "training set." The performance characteristics and expected ranges of the control material are established through internal assay and validation processes by the manufacturer.
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R & D Systems, Inc. R&D 5D Retic Hematology Control June 26, 2013
510(k) Summarv
JUL 2 4 2013
Submitter Information
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Contact: Ambreen Athar Phone: 612-379-2956 (ext. 4136) Fax: 612-379-6580 Date Prepared: June 26, 2013
Device Information
Proprietary Name: Common Name: Classification Classification Name: Product Code: Device Class: Panel:
R&D 5D Retic Hematology Control Hematology Controls 21 CFR 864.8625 Hematology Quality Control Mixture льк 11 Hematology (81)
Unmodified Predicate Device
R&D Systems CBC-5D Plus Retics Hematology Control, (K072096) manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413.
Description of Device
The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.
Intended Use:
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
Technological Comparison to Predicate
The modified device has the same technological characteristics as the legally marketed predicate device. Both are used to perform quality control assays and both products are used to monitor values obtained from Coulter® hematology analyzers. The predicate device is assaved for WBC, HGB, HCT, MCV, MCH, MCHC, RDW-SD, RDW-CV, PLT, MPV, NEUT #, LYMPH #, MONO #, EO #, BASO #, NEUT%, MONO%, LYMPH%, E0%, BASO%, NRBC#, NRBC%, RBC, RET%, RET%, and IRF whereas the R&D 5D Retic Hematology Control is assayed for only RET%, RET#, IRF, and MRV parameters.
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Summary of Performance Data
Laboratory testing of 3 validation lots has shown the R&D 5D Retic Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. The R&D 5D Retic Hematology Control passed the acceptance criteria of remaining within range over the life of the product. Expiration dating will be established at 105 days (closed vial) and 14 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.
Substantial Equivalence Conclusion
The data demonstrate that the R&D 5D Retic Hematology Control is substantially equivalent to the legally marketed predicate device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2013
R&D SYSTEMS, INC. c/o MS. AMBREEN ATHAR QA/RA SPECIALIST 614 MCKINLEY PLACE, N.E. MINNEAPOLIS MN 55413
Re: K130962
Trade/Device Name: R&D 5D Retic Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture Regulatory Class: II Product Code: JPK Dated: June 26, 2013 Received: July 12, 2013
Dear Ms. Athar:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the
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Page 2-Ms. Ambreen Athar
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRI-1'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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Maria M. Chan -S
Maria M. Chan. Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130962
Device Name: R&D 5D Retic Hematology Control
Indications for Use:
R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.
For in vitro Diagnostic Use Only.
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 Diagnostics and Radiological Health (OIR)
Leonthena R. Carrington -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k): K130962
§ 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.