MICRO21 WITH RETIC

K960776 · Triangle Biomedical Sciences, Inc. · JOY · May 17, 1996 · Hematology

Device Facts

• Record ID: K960776
• Device Name: MICRO21 WITH RETIC
• Applicant: Triangle Biomedical Sciences, Inc.
• Product Code: JOY · Hematology
• Decision Date: May 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5260
• Device Class: Class 2

Intended Use

The MICRO21™ with Retic is an automated microscopic system that locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure.

Device Story

Automated microscopic system; processes blood wedge smears stained with supravital stain. Instrument locates 1000 RBCs; captures/stores high-magnification (1000x) color images of reticulated RBCs. Images displayed on color monitor for technologist review. Technologist confirms presence of retic markings; eliminates non-retic images. System outputs report of percent retics per 1000 RBCs. Used in clinical laboratory settings; operated by technologists. Assists in Reticulocyte Count procedure; replaces manual microscopic scanning; improves efficiency by pre-selecting candidate cells for human verification.

Clinical Evidence

Bench testing performed on 80 slides from 40 patient samples. Method comparison (NCCLS EP-9) between MICRO21 and manual counting showed a 0.95 mean correlation. Sensitivity testing on 39 slides (39,000+ RBCs) demonstrated 99.7% agreement with technologist identification of reticulated RBCs.

Technological Characteristics

Automated microscopic system; 1000x magnification; color digital imaging; bar code slide identification; frame holder mechanism. Software-based image processing for cell location and storage. Standalone instrument.

Indications for Use

Indicated for use by laboratory technologists to aid in performing Reticulocyte Count procedures by locating, storing, and displaying images of reticulated red blood cells from blood wedge smears stained with a supravital stain.

Regulatory Classification

Identification

An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

Predicate Devices

• MICRO21™ with WBC Diff (K925670/A)

Submission Summary (Full Text)

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iMi
Intelligent Medical Imaging, Inc.
MAY 17 1996
K960776

# 510(K) SUMMARY

Prepared by: Christine B. Harper, MBA,MT(ASCP)
Title: Senior Product Development Manager
Date: February 7, 1996

Trade Name: MICRO21™ with Retic
Classification Name: Automated Cell Locating Device
Classification Number: 81JOY
Class: II
Regulation Number: 864.5260

The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.

## Description:

The MICRO21 with Retic is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays reticulated red blood cells (retics) to aid the technologist in performing the Reticulocyte Count procedure. A retic is defined as a nonnucleated Red Blood Cell (RBC) that contains two or more blue-stained particles or granulofilamentous material after staining with a supravital stain. A summary of the MICRO21 with Retic process is as follows:

1. Prepare a blood wedge smear stained with a supravital stain.
2. Affix a bar code to each slide, place the slides into a frame holder, and insert the frame into the MICRO21.
3. The instrument locates 1000 RBCs.
4. The reticulated RBCs are stored as high magnification color images (1000x magnification).
5. The images of retics stored by the instrument are displayed on a color monitor for review by a technologist.
6. The technologist confirms that each reticulated RBC image displayed contains retic markings. If the image does not contain retic markings, the image is eliminated by the technologist and consequently not included in the retic count.
7. A report of the percent of retics per 1000 RBCs is printed.

Page 3 of 28
Corporate: 4360 Northlake Blvd., Suite 214 • Palm Beach Gardens, FL 33410
Phone [phone] • FAX [phone]

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IMI
Intelligent Medical Imaging, Inc.

## Test Methods:

Two testing methods were performed to validate the safety and effectiveness of the *MICRO21* with Retic process. To conduct the tests, two slides were created from forty patient samples, (80 slides in total) including normal and abnormal values.

Test Method One employed the NCCLS EP-9 requirements for qualifying a new methodology versus the manual methodology being replaced. Using forty specimens with two slides from each specimen for a total of 80 slides, two technologists independently performed a manual retic count on each of the 80 slides. The same 80 slides were run on the *MICRO21* with Retic with the two technologists reviewing the reticulated RBCs displayed by the *MICRO21*. The results of the 80 manual retic counts and the 80 *MICRO21* retic counts were analyzed against the NCCLS EP-9 Mean Correlation Standard. The *MICRO21* with Retic and the manual method showed a .95 mean correlation, which is within the NCCLS EP-9 requirements for a new methodology.

Test Method Two involved two certified technologists independently observing the *MICRO21*'s ability to locate RBCs and reticulated RBCs on 39 slides. Over 39,000 RBCs were located by the *MICRO21* with a sensitivity (agreement with the technologist) of 99.7%.

## Conclusion:

The correlation determined by Test Method One, and the sensitivity determined by Test Method Two confirm the safety and effectiveness of the *MICRO21* with Retic for the intended use of location, storage and display of reticulated RBC’s to aid the technologist in performing the Retic Count procedure.

Page 4 of 28
Corporate: 4360 Northlake Blvd., Suite 214 • Palm Beach Gardens, FL 33410
Phone [phone] • FAX [phone]