(75 days)
No
The document describes a hematology control reagent used for calibrating and verifying a hematology analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the stability and performance of the control material itself.
No
This device is an in vitro diagnostic reagent used to monitor reticulocyte values obtained from a hematology system, not to treat or cure a disease.
No
The device is a control used to verify accuracy and precision of diagnostic devices, not a diagnostic device itself.
No
The device is described as an in vitro diagnostic reagent composed of physical materials (human erythrocytes, reticulocyte surrogate, plasma-like fluid, preservatives). It is a control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "tri-level, assayed hematology control designed to document and monitor reticulocyte values obtained from the CELL-DYN® 3500 System." This indicates it is used in a laboratory setting to evaluate the performance of a diagnostic instrument.
- Device Description: The description states it is an "in vitro diagnostic reagent composed of human erythrocytes and a reticulocyte surrogate suspended in a plasma-like fluid with preservatives." The term "in vitro diagnostic reagent" directly identifies it as an IVD. It also describes its use in "verifying accuracy and precision of CELL-DYN® 3500 reticulocyte results," which is a key function of an IVD control.
- Predicate Device: The mention of a predicate device (K943336; R&D Retic-I™) is common for IVD submissions to regulatory bodies, further supporting its classification as an IVD.
Based on the provided information, the primary purpose of this device is to be used in vitro (outside the body) to assess the performance of a diagnostic test (reticulocyte counting on the CELL-DYN® 3500 System). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
R&D Retic-PG™ is a tri-level, assayed hematology control designed to document and monitor reticulocyte values obtained from the CELL-DYN® 3500 System.
Product codes
Not Found
Device Description
R&D Retic-PG is an in vitro diagnostic reagent composed of human erythrocytes and a reticulocyte surrogate suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of CELL-DYN® 3500 reticulocyte results. CELL-DYN is a trademark of Abbott Diagnostics, Abbott Park, Illinois. R&D Retic-PG is available in three levels of reticulocytes and is stained and run in the same manner as patient specimens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The determination of substantial equivalence is based on an assessment of performance data. Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 62 days from shipment if stored at 2 -8°C. The open-vial stability is 20 days.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a logo for R&D Systems. The logo features the letters "R" and "D" in a bold, sans-serif font, with an ampersand (&) placed between them. Below the letters, the word "SYSTEMS" is written in a smaller, sans-serif font. The overall design is simple and professional, with a focus on the company's name.
Image /page/0/Picture/2 description: The image shows the date JUL 15 1996. The month is JUL, the day is 15, and the year is 1996. The text is in bold font.
510/k) SUMMARY R&D Retic-PG™ HEMATOLOGY CONTROL
| Date of Summary: | April 30, 1996 |
|---|---|
| Company/Institution name: | R&D Systems, Inc. |
| 614 McKinley Place N.E. | |
| Minneapolis, MN 55413-2647 | |
| Contact Person: | Sue Gallo Phone: (612) 379-2956 |
| &label> |
Substantial equivalence:
R&D Retic-PG Hematology Control is substantially equivalent to R&D Retic-I™, a hematology reticulocyte control currently being sold for in vitro diagnostic use. R&D Retic-I™ is a trademark of R&D Systems, Inc., 614 McKinley Place N. E., Minneapolis, MN 55413. The FDA document number for the predicate device, R&D Retic-I™, is K943336.
Device description:
R&D Retic-PG is an in vitro diagnostic reagent composed of human erythrocytes and a reticulocyte surrogate suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of CELL-DYN® 3500 reticulocyte results. CELL-DYN is a trademark of Abbott Diagnostics, Abbott Park, Illinois. R&D Retic-PG is available in three levels of reticulocytes and is stained and run in the same manner as patient specimens.
Intended use:
R&D Retic-PG™ is a tri-level, assayed hematology control designed to document and monitor reticulocyte values obtained from the CELL-DYN® 3500 System.
Comparison of R&D Retic-PG™ to the predicate device:
R&D Retic-PG™ has the same intended use as the predicate device. The products are used for different reliculocyte counting methods. The composition of R&D Retic-PG™ is the same as the predicate device except a reticulocyte surrogate is used instead of mammalian reticulocytes.
Discussion of performance data:
The determination of substantial equivalence is based on an assessment of performance data. Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 62 days from shipment if stored at 2 -8°C. The open-vial stability is 20 days.
Conclusions:
R&D Retic-PG™ is intended for use as a control to monitor the stability of reticulocyte values on the Abbott Cell-Dyn 3500 Hematology System. The stability data demonstrate that R&D Retic-PG™ is a stable material suitable for monitoring the performance of reticulocyte determinations on the Abbott Cell-Dyn 3500 System. R&D Retic-PG™ is substantially equivalent to R&D Retic-I currently sold for in vitro diagnostic use.
Submitted by:
Sue Sallo
Quality Assurance Coordinator
R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
Phone: (612) 379-2956 FAX: (612) 379-6580
-18
WATS: (800) 428-4246 WATS: (800) 523-3395
Customer Service Technical Service & QC Program