← Product Code [JPK](/productcode/JPK) · K961673 # R&D RETIC-PG HEMATOLOGY CONTROL (K961673) _R&D Systems, Inc. · JPK · Jul 15, 1996 · Hematology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K961673 ## Device Facts - **Applicant:** R&D Systems, Inc. - **Product Code:** [JPK](/productcode/JPK.md) - **Decision Date:** Jul 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.8625 - **Device Class:** Class 2 - **Review Panel:** Hematology ## 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. ## Device Story R&D Retic-PG is an in vitro diagnostic reagent consisting of human erythrocytes and a reticulocyte surrogate in plasma-like fluid with preservatives. Used in clinical laboratories to verify performance of Abbott CELL-DYN 3500 hematology analyzers. Provided in three levels; processed and analyzed identically to patient specimens. Serves as a quality control material to monitor reticulocyte count stability and instrument accuracy. Benefits patient care by ensuring reliable diagnostic results for reticulocyte analysis. ## Clinical Evidence Bench testing only. Stability studies confirmed recovery of values within expected ranges throughout product shelf life (62 days from shipment at 2-8°C) and open-vial stability (20 days). ## Technological Characteristics Tri-level hematology control mixture. Composition: human erythrocytes and reticulocyte surrogate in plasma-like fluid with preservatives. Form factor: liquid reagent. Storage: 2-8°C. No electronic or software components. ## Regulatory 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). ## Special Controls *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. ## Predicate Devices - R&D Retic-I™ ([K943336](/device/K943336.md)) ## Reference Devices - CELL-DYN® 3500 System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K961673 # RJD SYSTEMS JUL 15 1996 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 Fax: (612) 379-6580 Trade name: R&D Retic-PG™ Classification/Common Name: Hematology Quality Control Mixture (per 21 CFR 864.8625) Classification Code/Device Class: 81JPK Hematology Control Mixtures for Quality Control/Class II ## 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 reticulocyte 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 Gallo Sue Gallo, B.S., M.T. (ASCP) Quality Assurance Coordinator R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Phone: (612) 379-2956 FAX: (612) 379-6580 WATS: (800) 428-4246 WATS: (800) 523-3395 Customer Service Technical Service & QC Program --- **Source:** [https://fda-staging.innolitics.com/device/K961673](https://fda-staging.innolitics.com/device/K961673) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com