The ACIS Automated Cellular Imaging System is intended for & In Vitro Diagnostic Uses as an aid to the pathologist in the classification and counting of cells of interest based on particular color, size and shape.

Device Description

The Automated Cellular Imaging System (ACIS) device is an automated intelligent microscope cell locating device that detects cells (objects) of interest, by color and pattern recognition techniques. The system consists of software resident in computer memory and includes keyboard, color monitor, microscope, printer, and automatic slide handlinq equipment controlled and operated by a health care professional for interpretation and diagnosis.

AI/ML Overview

The ChromaVision Medical Systems, Inc. Automated Cellular Imaging System (ACIS) is intended as an aid to pathologists in the classification and counting of cells of interest. The studies provided demonstrate the device's reproducibility, accuracy, sensitivity, and specificity, particularly in the context of identifying cytokeratin-positive tumor cells in bone marrow specimens.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined quantitative acceptance criteria in a formal table with pass/fail thresholds. Instead, it presents performance characteristics and studies demonstrating the device's capabilities in comparison to manual methods and between instruments/pathologists. Based on the reported findings, the implicit acceptance criteria appear to be:

Performance Characteristic	Implicit Acceptance Criteria	Reported Device Performance
Reproducibility	Consistent identification and presentation of specific cells (XY coordinates) across multiple runs and instruments. Minimal variability in cell counts across runs, instruments, and pathologists.	Between-Instrument Reproducibility (Study 1): 100% reproducibility in identifying the same tumor cells by location across 3 ACIS systems over repeated scanning (n=27, 3 slides run 3 times on 3 ACIS). CV% and SD were 0. Between-Instrument Reproducibility (Study 2): Perfect agreement in tumor cell counts (CV% and SD of 0 for all variance components) across 3 ACIS systems over repeated runs (5 times each) by the same pathologist, for 4 cytospin slides (2 biological, 2 spiked). Between-Pathologist Reproducibility: Differences in tumor cell counts between pathologists for ACIS-assisted method (-3 to +32) were similar to manual counts (-4 to +13), indicating ACIS does not exacerbate inter-pathologist variability.
Accuracy / Correlation	High agreement with manual microscopy in identifying the presence or absence of tumor cells.	Study 1 (Spiked Specimen): 100% overall agreement between ACIS-assisted reading and manual microscopy for identifying the presence or absence of tumor cells in 30 spiked and normal bone marrow slides. Study 2 (Real Tumor Specimen): In 17 out of 39 cases (44%), ACIS-assisted method identified tumor cells that were overlooked by manual microscopy. In 3 cases, ACIS-assisted method re-classified specimens as non-tumor, contradicting manual microscopy. These discrepancies were verified by a second blinded independent manual and ACIS read by a third pathologist, with 100% verification of ACIS observations (21 of 21 cases).
Sensitivity	Ability to detect tumor cells, including those difficult to identify manually.	ACIS-assisted method identified tumor cells that were initially overlooked by manual microscopy in 17 out of 39 cases (44%). This suggests improved sensitivity over manual microscopy in these challenging real tumor specimens.
Specificity	Ability to correctly identify the absence of tumor cells.	In Study 1 (Spiked Specimen), ACIS-assisted method correctly identified 10 out of 10 cases without tumor cells, demonstrating 100% specificity for absence of tumor. In Study 2 (Real Tumor Specimen), ACIS-assisted method led to re-classification of 3 cases from positive (manual) to negative, implying ACIS can aid in more specific identification.

2. Sample Size Used for the Test Set and Data Provenance

Reproducibility Study 1:
- Test Set Sample Size: 3 full slides, each run 3 times on 3 different ACIS systems (total of 27 runs).
- Data Provenance: Clinical specimens (heparinized bone marrow) from human subjects with breast cancer. Prospectively processed for the study.
Reproducibility Study 2:
- Test Set Sample Size: 4 cytospin slides (2 biological from human donors with breast cancer, 2 spiked from normal human donors) each read 5 times on 3 different ACIS systems (total of 60 reads).
- Data Provenance: Heparinized bone marrow from human subjects with breast cancer (biological) and normal human donors spiked with tissue-cultured human carcinoma cells (spiked). Prospectively processed for the study.
Accuracy/Correlation Study 1 (Spiked Specimen):
- Test Set Sample Size: 30 slides (2 sets of 10 spiked slides with approx. 4 and 50 tumor cells respectively, plus an additional set of 10 normal human bone marrow slides).
- Data Provenance: Normal human bone marrow specimens, either spiked with tissue-cultured human breast carcinoma cells or normal. Prospectively processed for the study.
Accuracy/Correlation Study 2 (Real Tumor Specimen):
- Test Set Sample Size: 39 heparinized human bone marrow specimens from patients with breast cancer.
- Data Provenance: Clinical specimens (heparinized human bone marrow) from patients with breast cancer. Retrospective, as these were "actual human clinical tumor specimens" analyzed at a later date, but the manual reads were done initially for clinical purposes.
Between Pathologist Reproducibility Study:
- Test Set Sample Size: 11 slides.
- Data Provenance: Heparinized bone marrow from human subjects with breast cancer. Prospectively processed for the study.

The country of origin for the data is not specified, but the specimens are from human subjects/patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Reproducibility Study 1: Ground truth for tumor cell locations (XY coordinates) was established by an "exhaustive manual scan" on each slide. The identified tumor cells by the pathologist during the review process were compared to these manual scans. While a pathologist performed the manual scan, the exact number beyond "a pathologist" and their specific qualifications are not detailed beyond being capable of "intensive examination."
Reproducibility Study 2: Ground truth (initial manual count) was established by the "same pathologist" who later used the ACIS. Qualifications are not specified.
Accuracy/Correlation Study 1: Ground truth for the presence/absence of tumor cells was based on the knowledge of spiking (for spiked samples) and confirmed by "manual microscopy" for the overall agreement comparison. A "single pathologist" read the slides manually and with ACIS. Qualifications are not specified.
Accuracy/Correlation Study 2:
- Initial ground truth (manual microscopy results) was established by "two different pathologists in two different laboratories" for each of the 39 specimens.
- For verification of discrepant results, a "third pathologist" performed a "second blinded independent manual and ACIS read."
- Qualifications of these pathologists are not specified beyond being pathologists.
Between Pathologist Reproducibility Study: Ground truth was not explicitly established as the study aimed to compare inter-pathologist variability. "Two different pathologists" read the 11 slides manually and with ACIS. Qualifications are not specified.

4. Adjudication Method for the Test Set

Reproducibility Study 1: Comparison against an "exhaustive manual scan" (presumably by a single expert) to ensure consistent cell presentation. No explicit adjudication process for disagreements is mentioned, as the system achieved 100% agreement.
Reproducibility Study 2: Comparison against an "initial manual count" by the same pathologist. No explicit adjudication process for disagreements is mentioned, as the system achieved perfect agreement.
Accuracy/Correlation Study 1: For spiked specimens, the "number of cases with tumor" was known by design (spiking levels). For the "correlation" part (ACIS vs. Manual), the single pathologist was blinded to the other method's results. No specific adjudication for discordant results is described, as 100% overall agreement was reported.
Accuracy/Correlation Study 2:
- Initial manual reads were done by two different pathologists.
- For the reported table comparing manual to ACIS-assisted, it seems the combined manual results served as a reference.
- For the 20 discrepant cases (17 positive by ACIS, 3 negative by ACIS confirmed on re-analysis), these were further verified by a "third pathologist" using "blinded re-analysis" with both manual and ACIS methods. This implies an adjudication process where the third pathologist's findings served to confirm the ACIS observations.
Between Pathologist Reproducibility Study: No adjudication method described as it was a study of inter-pathologist variability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Yes, elements of MRMC comparative effectiveness were included, particularly in Accuracy/Correlation Study 2 and the Between Pathologist Reproducibility Study.

Accuracy/Correlation Study 2: This study involved multiple readers (two initial pathologists, then a third for verification) and multiple cases (39 real tumor specimens). It compared manual microscopy to ACIS-assisted reading.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: In 17 out of 39 cases (44%), the pathologist was successful in identifying tumor cells with the assistance of the ACIS device that "had been overlooked using manual microscopy." This indicates a substantial improvement in detection for these challenging cases. Additionally, in 3 cases, ACIS assistance led to a re-classification from positive to negative, suggesting improved specificity or reduction in false positives. The impact of the ACIS in improving pathologist performance is significant, as it allowed detection of previously missed positive cases and led to re-evaluation of others.
Between Pathologist Reproducibility Study: While not directly quantifying improvement, it noted that "the differences in tumor cell counts between the pathologists ranged from -4 to +13 for manual counts and from -3 to +32 for ACIS-assisted tumor cell counts. The differences were similar for both methods." It concluded that ACIS provides "an equal or greater number of candidate cells for classification" and "the differences which exist between pathologists in their identification procedures are not expected to be affected by use of the ACIS device." This suggests ACIS doesn't worsen inter-reader variability, and potentially provides more comprehensive data for review.

6. If a Standalone Study Was Done

The ACIS is described as "an aid to the pathologist," and all studies describe "ACIS-assisted" performance or involve a pathologist's review of ACIS output (e.g., location of IHC stained positive cells, montage images).

While the system does automatically detect cells ("detects cells (objects) of interest, by color and pattern recognition techniques"), the performance data consistently integrates the pathologist's interpretation as part of the overall system's effectiveness. Therefore, a purely standalone (algorithm only without human-in-the-loop performance) study is not explicitly presented in this document. The results always reflect a human-AI collaboration.

7. The Type of Ground Truth Used

The ground truth varied depending on the study:

Expert Consensus / Expert Review:
- Reproducibility Study 1: An "exhaustive manual scan" presumably by an expert pathologist, serving as the reference for XY coordinates.
- Reproducibility Study 2: "Initial manual count" performed by a pathologist.
- Accuracy/Correlation Study 2: Initial "manual microscopy" performed by two pathologists. Discrepant findings were further verified by a "second blinded independent manual and ACIS read by a third pathologist." This leans heavily on expert review/consensus.
Known by Design (Spiked Samples):
- Accuracy/Correlation Study 1: For the spiked specimens, the presence and approximate number of tumor cells were "known" by the nature of the experimental setup (spiking with known numbers of cells). This served as a strong reference for accuracy.

No mention of pathology or long-term outcomes data as direct ground truth.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set used to develop or train the ACIS algorithms. The focus of this 510(k) summary is on the validation studies demonstrating the device's performance after its development.

9. How the Ground Truth for the Training Set Was Established

Since a training set size is not provided, the method for establishing its ground truth is also not detailed in this document.

Summary

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JUL 28 1999

K984188

510 (k) Summary of Substantial Equivalence ChromaVision Medical Systems, Inc. (Automated Cellular Imaging System)

This summary of substantial equivalence information is furnished in accordance with 21 CFR 807.92 as follows:

21 CFR 807.92(a) :

21 CFR 807.92 (a) (1) :

Submitter's name and address:

ChromaVision Medical Systems, Inc. 33171 Paseo Cerveza San Juan Capistrano, California 92675

Submitter's telephone number: (949) 443-3355
Contact person:

Michael Schneider Mr. ChromaVision Medical Systems, Inc. 33171 Paseo Cerveza San Juan Capistrano, California 92675

Date this 510(k) summary was prepared: June 24, 1999.

21 CFR 807.92 (a) (2) :

Trade/proprietary name of the device: ACIS (Automated Cellular Imaging System)
Classification name: Automated microscopy cell locating workstation

21 CFR 807.92 (a) (3) : Legally marketed predicate devices to which substantial equivalence is claimed:

★ Digital analyzer: ChromaVision Medical Systems, Inc.'s Model

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classified under 21 CFR 864.5260 as an automated cell locating device.

Automated microscope feature: Nikon Biostation, exempt from * Premarket Notification in accordance with 21 CFR 864.3600. Cell locatinq feature: Intelligent Imaging, Inc., Model IMS-★ 200, automated cell locating device found substantially equivalent on July 23, 1993(K925670/A). Such devices are classified under 21 CFR 864.5260.

Human manual visualization by conventional microscopy. *

21 CFR 807.92(a) (4) : Description of the device that is the subject of this premarket notification:

21 CFR 807.92(a) (5) : Intended use and labeled indications for use :

21 CFR 807.92(a)(6): Technological characteristics:

The design, construction, enerqy source, and other characteristics of the ACIS candidate device are considered to be substantially equivalent to the relevant features of the predicate devices. A summary of the technological characteristics of the ACIS candidate device in comparison to those of the predicate devices follows:

Method of cell detection: The same as the predicate devices; i.e., colorimetric pattern recognition by microscopic examination of prepared cells by size, shape, hue, and intensity as observed

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Method of cell detection: The same as the predicate devices; i.e., colorimetric pattern recognition by microscopic examination of prepared cells by size, shape, hue, and intensity as observed by an automated computer controlled microscope and/or by visual observation by a health care professional.
System components: The system components comprising the candidate device are substantially equivalent to those in the predicate devices; i.e., computer, microscope, color monitor(s), keyboard, printer, automatic loading and positioning of prepared sample on microscope stage, automatic focusing of microscope, and automatic storage of acquired images.
Energy source: The electrical service is 120 VAC 60 HZ, the same as the predicate devices.

21 CFR 807.92(b): 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on performance data shall contain the following information:

21 CFR 807.92(b) (1): The conclusion (and summary of performance data) drawn from the non-clinical and/or clinical tests that demonstrate the ACIS candidate device is as safe, is as effective, and performs as well or better than the predicate devices:

PERFORMANCE CHARACTERISTICS

The ACIS Automated Cellular Imaging System demonstrates exceptional reproducibility, both within and between instruments, as well as improved sensitivity compared to manual microscopy.

REPRODUCIBILITY

Between-Instrument Reproducibility

Two studies were conducted to evaluate the ability of multiple ACIS systems to correctly identify the number and location of IHC

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stained cytokeratin-positive cells on study slides.

Study 1. The first study, described below, evaluated the ability of 3 ACIS systems to identify the same tumor cells in multiple runs (n=27). This study was conducted to assess the ability of multiple ACIS systems to consistently present the same cytokeratin-positive cells in the montage images to one reviewing pathologist.

Using clinical specimens, the ACIS system was shown to aid in the identification of the same cells (objects) by location with 100% reproducibility during repeated scanning (n=27 - 3 slides run 3 times on 3 ACIS) of the same slide.

Summary of Study 1: The slides for this study were prepared using heparinized bone marrow specimens from human subjects with breast cancer (air dried, fixed in formalin and methanol, and stained with a monoclonal anti-cytokeratin antibody (BM2), and using an indirect secondary detection system consisting of a secondary antibody, alkaline phosphatase enzyme-conjugated streptavidin complex and Fast Red chromogen, and hematoxylin counterstain).

Three slides were randomly chosen, and an exhaustive manual scan was done to record the XY coordinates of identified tumor cells on each entire slide. Each study slide was then read on 3 different ACIS systems in 3 separate runs over several days. The XY coordinates of cytokeratin positive cells identified by the pathologist during the review process were recorded and compared to the manual scans. The study was conducted with intensive examination of each slide in order to minimize the effect of pathologist variability in the identification of tumor cells, and to assess the repeatability of the system itself in presenting the same cells for review. The results showed that in all 27 runs, each ACIS instrument recorded the same tumor cells as those identified by the pathologist for each study slide, and presented them in the montage. The coefficient of variation (CV%) and standard deviation (SD), both within and between instrument, were 0. Examination of the XY coordinates for the positively stained cells showed exact agreement with the manual method and for all runs and instruments.

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In a second study, the number of positive-staining Study 2. tumor cells identified by one pathologist using 3 ACIS systems was compared with manual counts and between multiple ACIS systems. The slides for this study were prepared using heparinized bone marrow from human subjects with breast cancer (air dried, fixed in formalin and methanol, and stained with a monoclonal anti-cytokeratin antibody (BM2), and using an indirect secondary detection system consisting of a secondary antibody, alkaline phosphatase enzyme-conjugated streptavidin complex and Fast Red chromogen, and hematoxylin counterstain).

The ACIS aided the pathologist to count the same quantity of tumor cells on repeated analyses of the same slide using 3 different instruments.

Summary of Study 2. In the second study, 4 cytospin study slides were employed: 2 biological bone marrow slides (heparinized bone marrow slides from selected human donors with breast cancer), and 2 spiked bone marrow slides (heparinized bone marrow specimens from selected normal human donors spiked with a known number of tissue-cultured human carcinoma cells). Each slide was then read 5 times on 3 different ACIS systems over a several week period of time by the same pathologist. In this study, as in the one described above, perfect aqreement was seen both within and between instruments, as well as with the initial manual count (both CV% and SD of 0 for all variance components). Aqain, the study was conducted to minimize the effect of pathologist variability in the assessment of the system's ability to consistently (between multiple instruments over different runs on different days) present the same cells of clinical interest.

These two experiments showed that the ACIS consistently records the cells of interest and presents them in the montage.

ACCURACY, SENSITIVITY and SPECIFICITY

Two studies were conducted to evaluate the accuracy, sensitivity, and specificity of the ACIS system.

Study 1. Manual Microscopy vs. ACIS, Spiked Specimen

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Correlation Study

The first study was conducted using spiked specimens to further evaluate the performance of the ACIS device in assisting the pathologist to identify tumor cells. Two sets of ten slides each (total of 20 slides) were made with normal human bone marrow specimens spiked with approximately 4 (low) and 50 (hiqh) tissuecultured human breast carcinoma cells per slide, respectively, with normal cell counts of approximately 500,000 per slide. These slides were air dried, fixed in absolute acetone, and stained with a monoclonal anti-cytokeratin antibody (CK18). An indirect secondary detection system was used which consisted of a secondary antibody, alkaline phosphatase enzyme-conjugated streptavidin complex and Fast Red chromoqen, and hematoxylin counterstain. An additional set of 10 normal human bone marrow slides with approximately 500,000 cells per slide were identically processed and randomly inserted into the reading sequence. A single pathologist read the slides both manually and with the assistance of the ACIS device.

The pathologist was blinded to the results of each alternative reading method and each method was performed at a different time on a different day. The results of this study are as follows:

	Number ofCases withPositiveTest Resultsby ACIS	Number ofCases withNegativeTest Resultsby ACIS	Totals
Cases withTumor Cells(n=20) *	20	0	20
CaseswithoutTumor Cells(n=10) *	0	10	10
Totals	20	10	30

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Overall agreement to identify the presence or absence of tumor cells = 100%

Tumor cell counts were confirmed by manual microscopy.

Manual Microscopy vs. ACIS, Real Tumor Specimen Study 2. Correlation Study.

The second study examined the correlation of manual microscopy and the ACIS device using actual human clinical tumor specimens. Thirty nine heparinized human bone marrow specimens from patients with breast cancer (air dried, fixed in formalin and methanol, and stained with a monoclonal anti-cytokeratin antibody (BM2), and using an indirect secondary detection system consisting of a secondary antibody, alkaline phosphatase enzyme-conjugated streptavidin complex and Fast Red chromogen, and hematoxylin counterstain) were analyzed by two different pathologists in two different laboratories using manual microscopy. They each recorded the number of tumor cells identified on each slide. At a later date, under blinded conditions (different barcodes), the same slides were analyzed using the ACIS device and the number of tumor cells on each slide was recorded by the same two pathologists. The results of this study are as follows:

	Positive byManualMicroscopy	Negative byManualMicroscopy
Positive byACIS-AssistedMethod	9	17
Negative byACIS-AssistedMethod	3	10

Utilizing the higher magnification and enhanced resolution of the ACIS device, in 17 out of 39 cases (44%), the pathologist was successful in identifying the presence of tumor cells when such cells had been overlooked using manual microscopy. Also, in 3

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cases the pathologist identified the presence of tumor cells using manual microscopy and then re-classified those specimens as non-tumor with the assistance of the ACIS device. The discrepant results were further verified by "blinded" reanalysis of 21 of the original 39 specimens, 17 of which were originally called positive for tumor cells by ACIS review and three of which were called negative for tumor cells by ACIS review. The ACIS observations were confirmed by a second blinded independent manual and ACIS read by a third pathologist.

Two independent ACIS-assisted reads and one manual read by different pathologists showed 100% verification of slide diagnosis (21 of 21 cases) using ACIS.

Between Pathologist Reproducibility Study

This study was conducted to assess the variability of slide scores obtained when two pathologists read the same slides independently.

The slides for this study were prepared using heparinized bone marrow from human subjects with breast cancer (air dried, fixed in formalin and methanol, and stained with a monoclonal anticytokeratin antibody (BM2), and using an indirect secondary detection system consisting of a secondary antibody, alkaline phosphatase enzyme-conjugated streptavidin complex and Fast Red chromogen, and hematoxylin counterstain).

11 slides were read by two different pathologists employing both the manual and ACIS-assisted methods.

The differences in tumor cell counts between the pathologists ranged from -4 to +13 for manual counts and from -3 to +32 for ACIS-assisted tumor cell counts.

The differences were similar for both methods. Since the ACIS provides the examining pathologist with an equal or greater number of candidate cells for classification, the differences which exist between pathologists in their identification

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procedures are not expected to be affected by use of the ACIS device.

Based on the results of the clinical studies described in this report, it is concluded that the ACIS device is as safe and effective (therefore substantially equivalent) as the predicate devices; and it provides the health care professional with an important, clinically relevant tool in identifying and classifying cellular objects of interest as a function of color and morphometry.

.... END OF 510(k) SUMMARY ....

June 24, 1999

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Re:

JUL 28 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Schneider ChromaVision Medical Systems 33171 Paseo Cerveza San Juan Capistrano, California 92675-4824

K984188 Trade Name: Automated Cellular Imaging System (ACIS) Regulatory Class: II Product Code: JOY Dated: June 2, 1999 Received: June 17, 1999

Dear Mr. Schneider:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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16984188 Page 1 of 1 510(k) number (if known): Unknown; not yet assigned by FDA. Device name: Automated Cellular Imaging System (ACIS) Intended use of the device: The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape. :)
『 this lir Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use __ Over-the-Counter Use or (Per 21 CFR 801.109)

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000002

Regulation Number and Section

§ 864.5260 Automated cell-locating device.

(a)
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.)(b)
Classification. Class II (performance standards).