SYSMEX SE/RAM-1

K964375 · Sysmex Corp. · GKL · Mar 13, 1997 · Hematology

Device Facts

• Record ID: K964375
• Device Name: SYSMEX SE/RAM-1
• Applicant: Sysmex Corp.
• Product Code: GKL · Hematology
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Intended Use

The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.

Device Story

Sysmex SE/RAM-1 is a table-top hematology analyzer combining SE-9000 blood cell counting and RAM-1 reticulocyte analysis units. System accepts EDTA anticoagulated whole blood via automated sampler; transports samples to bar code reader and mixing/cap piercing device. Sample split into 8 aliquots: 7 to SE-9000 for CBC parameters (RBC, Hgb, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, WBC, differential counts); 1 to RAM-1 for reticulocyte analysis (RETIC %, RETIC#). SE-9000 uses RF/DC biosensors and sheath flow; RAM-1 uses fluorescence intensity and forward scatter. Data Management System processes inputs; displays results on color monitor. Used in clinical laboratories by medical technologists to screen for abnormal blood specimens; technologists perform final review of abnormal results. System benefits include integrated workflow, consolidated data storage, and automated screening.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technology, reagents, and principles of operation to the predicate devices.

Technological Characteristics

Table-top analyzer; hydraulic and electronic systems (PROM and PC-based). Sensing: RF/DC biosensors, sheath flow, fluorescence intensity, and forward scatter. Connectivity: Barcode reader, printer, and Data Management System. Reagents: 13 total, identical to SE-9000/R-3000. Software: Integrated SE-DMS for data management and QC programs.

Indications for Use

Indicated for whole blood cell analysis and automated reticulocyte analysis in clinical laboratory settings using EDTA anticoagulated whole blood samples.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• Sysmex SE-9000 (K936023)
• R-3000 (K912494)

Submission Summary (Full Text)

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K964375
MAR 13 1997

# 510(k) Summary of Safety and Effectiveness

Sysmex Corporation of America
Gilmer Road 6699 RFD
Long Grove, IL 60047-9596
[phone]
Fax: [phone]
Attention: Cathy Trester
Date Prepared: December 10, 1996

## Sysmex™ SE/RAM-1, Trade name and Common name

The Sysmex™ SE/RAM-1 is substantially equivalent to the Sysmex™ SE-9000 (Premarket Notification K936023) and the R-3000 (Premarket Notification K912494). The Sysmex™ SE/RAM-1 is classified as a Class II device.

## Intended Use

The SE/RAM-1 is an In Vitro device for whole blood cell analysis in clinical laboratories. The SE-9000 portion is intended for blood cell analysis; the RAM-1 portion is intended for automated reticulocyte analysis. The instrument is a screening device for identifying abnormal blood specimens. Medical technologists are responsible for final review of abnormal cells.

## Device Description

The SE/RAM-1 is a table-top analyzer system consisting of a blood cell counting unit (SE-9000), a reticulocyte unit (RAM-1), a Data Management System, and a printer. A Sampler Unit is attached to the SE-9000 unit, which transports samples in cassette racks to the ID bar code reader and then to the Automatic mixing/Cap piercing device.

The SE/RAM-1 system has the capability of reporting up to 23 parameters. The 23 reportable parameters are as follows: RBC, Hgb, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, WBC, NEUT%, LYMPH%, MONO%, EO%, BASO%, NEUT#, LYMPH#, MONO#, EO#, BASO# (all from SE-9000 unit), RETIC %, RETIC# (from RAM-1 unit).

The SRV of the SE-9000 contains a port (in the original design of the instrument) by which the reticulocyte module (RAM-1) is attached. The SRV splits the blood sample into 8 aliquots. 7 aliquots are delivered to the SE-9000 system, diluted with the appropriate diluent or lyse and sent to their respective detector blocks for analysis. The 8th aliquot is sent to the RAM-1 where it is diluted and stained, then sent to the flow cell for analysis.

The SE/RAM-1 system uses a total of up to 13 reagents. All reagents are the same as used on the stand-alone SE-9000 and the R-3000 analyzers.

## Similarities and Differences of the SE/RAM-1 to SE-9000 and R-3000

Technology employed in the SE/RAM-1 system is exactly the same as is used in the SE-9000 and R-3000 analyzers. Differences are in software and minor tubing connections. All similarities and differences are described in Table 1.

## Conclusion

In conclusion, the Sysmex™ SE/RAM-1 is a combination of the SE-9000 and R-3000 analyzers in one operating unit. The modifications of the instrument do not raise new issues of safety and effectiveness. The data presented shows the SE/RAM-1 to be substantially equivalent to the SE-9000 and R-3000.

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Table 1: Comparison of Sysmex™ SE/RAM-1 System to Stand-alone SE-9000 and R-3000

| | SE-9000 | SE/RAM-1 SE-9000 portion | R-3000 | SE/RAM-1 RAM-1 portion |
| --- | --- | --- | --- | --- |
| Intended use | In Vitro Device for CBC analysis | same | In Vitro Device for reticulocyte analysis | same |
| Sample type | EDTA anticoagulated whole blood | same | EDTA anticoagulated whole blood | same |
| Sample pathway | Open or closed mode, through SE-9000 SRV | same | Open or closed mode, through R-3000 SRV | Open or closed mode, through SE-9000 SRV |
| Physical safety | See 510(k) #K936023 | same | See 510(k) #K912494 | same |
| Performance | #K936023 | same | #K912494 | same |
| Principles of Operation | | | | |
| -Biosensor system | RF/DC | same | n/a | n/a |
| -Sheath flow | used in RBC/Plt counting | same | used in counting system | same |
| -Scattergram/histo-gram | See description | same | See description | Scattergram now in color; discriminator lines not displayed |
| -Fluorescence intensity | n/a | n/a | used in counting | same |
| -Forward scatter | n/a | n/a | used in counting | same |
| Physical hardware | | | | |
| -Main unit | Hydraulic system Electronic system-PROM and PC based | same | Hydraulic system Electronic system-PROM based | same |
| -Power unit | power unit | same | n/a | n/a |
| -Laser power unit | n/a | n/a | LPU | same |
| -Pneumatic Unit | PU-1 | same | same as SE | share PU with SE |
| -Sampler/barcode reader | 10 rack sampler, LED | same | 5 rack sampler, LED | Uses SE sampler/barcode reader |
| Software Programs | | | All R software is part of SE-DMS | |
| -Display | full color display | Same elements as SE-9000 | monochrome display | Same elements as R-3000 (now part of SE-DMS display) |
| -Stored Data | 10000 sample storage | same | 500 sample storage | 10000(same as SE) |
| -QC program | 15 files, 180 points/file | same | 4 QC files, 60 points/file | 12 files, 180 points/file |
| -QC material | SE-Check | same | Ret-Check | same |
| -Maintenance | See 510(k) #K936023 | same | See 510(k) #K912494 | see description and RAM-1 Ops manual, Chapter 5 |