← Product Code [GKZ](/productcode/GKZ) · K960072 # SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX (K960072) _Biochem Immunosystems (U.S.), Inc. · GKZ · Mar 6, 1997 · Hematology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K960072 ## Device Facts - **Applicant:** Biochem Immunosystems (U.S.), Inc. - **Product Code:** [GKZ](/productcode/GKZ.md) - **Decision Date:** Mar 6, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The Spirit™, is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument. This device is designed for use in small to medium clinics. ## Device Story Spirit™ is a microprocessor-based, tabletop electronic hematology system for small/medium clinics. Input: whole blood samples. Operation: automated processing/analysis of multiple samples using three dedicated computers to manage tasks, replacing complex plumbing with electronic control. Output: 16 blood cell parameters displayed via structured computer program. Healthcare providers use output as part of clinical assessment; requires additional analysis for diagnosis. Benefits: higher throughput, lower cost, easier maintenance, and improved ease of use compared to conventional systems. ## Clinical Evidence Bench testing only. Device performance characteristics confirmed through design, development, and production procedures conforming to Good Manufacturing Practices. No clinical trial data provided. ## Technological Characteristics Microprocessor-based electronic hematology system; tabletop form factor. Architecture utilizes three computers for distributed task processing. Employs proprietary mathematical algorithms and computer programming stored in electronic memory/PROM for data analysis. Measures 16 whole blood parameters. ## 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 - System 9000 Plus, (Model 9018) ([K911626](/device/K911626.md)/B) ## 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} K960072 MAR - 6 1997 # Exhibit 14 ## Summary of Safety & Effectiveness The *Spirit™*, is a computerized, enhanced electronic Hematology System designed for clinical applications to allow 16 whole blood parameters to be measured by a small table top computer driven instrument. BioChem Immunosystems Incorporated has a history of developing such systems and offers this device as a technological innovation over conventional Hematology Systems. This device is designed for use in small to medium clinics. As such, this device is a Class II device, having Classification Name: Electronic Hematology System, Product Code: 81GKZ as described in 21 CFR Part 864.5220. BioChem Immunosystems Incorporated has determined that this device is substantially equivalent to a *predicate* medical device which is currently in commerce and has been submitted to the FDA via K911626/B as an electronic Hematology instrument and is identified as the System 9000 Plus, (Model 9018) also marketed by BioChem Immunosystems Incorporated. A determination of substantial equivalence is based upon: This device uses the same tried and proven chemistry but with fewer hardware parts. Instead of one computer, this new instrument would use three computers, each with a separate task as the process continued. The *Spirit™* uses more computers and less plumbing. Each process yields a higher throughput of analytical data resulting in a system easier to use, lower in cost and easier to maintain in the field. The *Spirit™ Hematology System* is a microprocessor based device which is designed to provide *identically the same clinical function* as the System 9000 Plus, (Model 9018). This compact device sits on any desktop. However, in addition, it provides a faithful analysis and display of key blood cells parameters by automatic processing and analyzing multiple samples and outputting test results via a structured computer program. Both the *Spirit™* and the System 9000 Plus, (Model 9018) retain an electronically stored data and act on that data using mathematical computations {proprietary algorithm} and computer programming {stored in a Electronic media and PROM} to provide blood parameters. Both the *Spirit™* and the System 9000 Plus, (Model 9018) are designed to measure multiple whole blood parameters during an unattended mode. Both provide the same acoustic qualities as the conventional mechanical Hematology System. Both devices retain a electronically stored sample and act on that sample using mathematical computations {proprietary algorithm} and computer programming stored in electronic memory to count whole blood parameters and issue measurements data relating to a specific patient/session for analysis. Neither device has claims or, is offered as, laboratory analysis equipment. Where either device is used, traditional medical practice requires additional analysis for any authentic diagnosis. The *Spirit™* provides a facility to analyze whole blood on a repeatable basis with conventional accuracy, as also does the System 9000 Plus, (Model 9018). The *Spirit™* has benefited from design, development, testing and production procedures that conform to Good Manufacturing Procedures. This device has performance characteristics substantially equivalent to its predicate device yet includes improvements to facilitate the various clinical applications for which it is intended. This device is safe and effective for the application for which it is intended and has been tested to confirm safety and efficacy. BioChem Immunosystems Incorporated continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product. ## CERTIFICATION: I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated device. ![img-0.jpeg](img-0.jpeg) Mr. Laurence Potter Director, Regulatory Affairs, Quality Assurance BioChem Immunosystems Incorporated 100 Cascade Drive Allentown, PA 18103-9562 Tel 610 266 4315 Fax 610 266 0184 12/27/95 Date Signed Sheet 1 of 1 --- **Source:** [https://fda-staging.innolitics.com/device/K960072](https://fda-staging.innolitics.com/device/K960072) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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