← Product Code [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ) · K061667 # CELL-DYN RUBY SYSTEM (K061667) _Abbott Laboratories · GKZ · Jul 10, 2006 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K061667 ## Device Facts - **Applicant:** Abbott Laboratories - **Product Code:** [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ.md) - **Decision Date:** Jul 10, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The CELL-DYN Ruby System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories and physician office laboratories. ## Device Story Tabletop automated hematology analyzer; processes EDTA-anticoagulated human whole blood samples. Uses MAPSST technology (laser flow cytometry) and optical absorbance (Helium Neon laser) to measure WBC, RBC, PLT, and HGB parameters. Features automated sample loader for up to 50 closed tubes; manual loading also supported. System includes analyzer, data module, touch-sensitive LCD, and barcode reader. Software provides wizards for complex processes, system logs, and remote monitoring via AbbottLink. Output displayed on screen, printed, or sent to LIS via RS232. Assists clinicians in hematological assessment by providing automated cell counts and differential parameters; aids in rapid patient specimen identification and data review through suspect flags and dispersional data alerts. ## Clinical Evidence Bench testing only; design control activities and verification/validation testing performed to confirm that modifications met predetermined acceptance criteria. ## Technological Characteristics Tabletop analyzer; laser flow cytometry (MAPSST) and optical absorbance (HeNe laser). Reagent heaters for WBC/HGB. Connectivity: USB, RS232 (LIS), CD/DVD drive. Software: Windows XP-based with GUI, touch-screen, barcode reader, and remote monitoring (AbbottLink). Automated sample loader (50-tube capacity). ## Regulatory Identification An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.” ## Predicate Devices - CELL-DYN 3200 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} SPECIAL 510(k): Device Modification ODE Review Memorandum To: THE FILE RE: DOCUMENT NUMBER K061667 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials. 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The change is the modification of the CELL-DYN 3200 System to the CELL-DYN Ruby System. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. The difference includes; an operating system update to Microsoft® Windows® XP, a mouse for software navigation and hand held barcode reader, the addition of WBC/Hemoglobin reagent heaters, a CD-ROM/DVD Drive to enable online maintenance, video/online Operator's manual and a software wizard for performing calibrations and precision. 4. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 5. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. (Reviewer's Signature) (Date) Comments Revised: 3/27/98 --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K061667](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K061667) **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. 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