Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointentinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other g.i. lesions that can bleed. Hemoccult ICT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.

Device Description

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. It incorporates multiple components including separate sample collection card(s), applicator sticks, test devices, buffer, patient instructions, physician instructions and product instructions for use.

AI/ML Overview

While the provided text describes the Hemoccult ICT device and its intended use, it does not explicitly state acceptance criteria in a quantifiable manner or present a clinical study that "proves the device meets the acceptance criteria" in the way one might expect for a new device seeking regulatory approval based on robust statistical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Hemoccult ICT, formerly FlexSure OBT, K961062). The "Summary of Performance Data" section provides some overall performance characteristics observed during evaluations, but these are presented as descriptive observations rather than predefined criteria or the results of a specific clinical trial designed to prove meeting those criteria.

Therefore, many of the requested points cannot be directly extracted from the provided text. I will answer based on the information that is available.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a tabulated format with specific thresholds that the device must meet. Instead, it describes general performance observations and states that the data "supports a finding of substantial equivalence."

Reported Device Performance (from "Summary of Performance Data"):

Performance Aspect	Reported Performance / Observation
Positivity Rate (Screening Population)	Approximately 2% in a screening population of average risk, asymptomatic individuals aged 50 or older. This was a general expectation from immunochemical fecal occult blood tests.
Positivity Rate (Multi-day, Young Volunteers)	Approximately 2% in a group of 88 young, presumed normal volunteers, ages 17-33, who did not follow a restricted diet. (Multi-day fecal collections, all returned collections of the three dispensed slides regardless of number of days).
Positivity Rate & Estimated Positive Predictive Value (Multi-day, Average Risk)	Multi-day screening positivity rate: 1.8%Estimated positive predictive value for colorectal neoplasia: 15.6%(In a group of 1734 average risk individuals, ages 41-97, who followed a restricted diet).
Clinical Sensitivity for Colorectal Cancer (High-Risk Patients)	90% (for multi-day screening in high-risk patients).
Clinical Sensitivity for Large Adenomas (High-Risk Patients)	28% (for multi-day screening in high-risk patients).
Sensitivity for Non-neoplastic Colorectal Lesions	Low (in high-risk patients study).

Note: The document states that "Equivalence is demonstrated through intended use, material composition, formulation, and clinical performance data analysis." The specific "acceptance criteria" for demonstrating this equivalence for each of these performance metrics are not detailed, but the reported performance figures are what was observed.

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

The document refers to "clinical performance data analysis" as a basis for demonstrating equivalence and mentions specific groups from which performance data was derived. These can be considered the test sets for calculating the reported performance metrics.

Sample Sizes:
- Group 1: 88 young, presumed normal volunteers, ages 17-33.
- Group 2: 1734 average risk individuals, ages 41-97.
- Group 3: "high risk patients" - specific number not provided, but studied for sensitivity to colorectal cancer and large adenomas. This study is referenced in the predicate device for "Clinical Performance Source Data."
Data Provenance: The document explicitly states "Clinical Performance Source Data: Same as Predicate HOICT." This implies the data was collected for the original predicate device (Hemoccult ICT, formerly FlexSure OBT, K961062). There is no mention of the country of origin. The data appears to be retrospective relative to the current 510(k) submission, as it originates from the predicate device's evaluation.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical performance data. Given the nature of a fecal occult blood test, the ground truth would typically be established through more definitive diagnostic procedures (e.g., colonoscopy with biopsy for pathology).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study is not described in the document. The device is a "visually read, qualitative immunochemical chromatographic method," implying human interpretation. However, the study focuses on the device's performance in detecting hemoglobin, not on comparing human readers' performance with and without AI assistance. This is a diagnostic test, not an AI-assisted diagnostic tool.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is described as "visually read," meaning human interpretation is an integral part of its normal operation. Therefore, a standalone study without human-in-the-loop performance would not be applicable, as it's not an automated algorithm in that sense. The results (presence/absence of color change) are interpreted by a human user.

7. The Type of Ground Truth Used

The nature of the reported performance metrics (e.g., "positive predictive value for colorectal neoplasia," "clinical sensitivity for colorectal cancer" and "large adenomas") strongly suggests that the ground truth was established through pathology or definitive diagnostic outcomes (e.g., colonoscopy with biopsy confirming polyps, adenomas, or cancer) for individuals who tested positive or were part of the relevant patient groups.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or machine learning model. This is a traditional diagnostic kit, not an AI/ML device. The clinical performance data mentioned would serve as evaluation data for the device itself.

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

As there is no mention of a training set for an algorithm, this question is not applicable based on the provided text.

Summary

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K080812

Summary of Safety & Effectiveness Hemoccult® ICT Immunochemical Fecal Occult Blood Test Kit

1.0 Submitted By:

Kim Walker, MS, RAC Global RA & QA Consultant C/O Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: (714) 273-9254 FAX: (714) 961-4234

JUN 2 5 2008

2.0 Date Submitted:

March 21, 2008

3.0 Device Name(s):

3.1 Proprietary Names Hemoccult® ICT
3.2 Classification Name Ocult blood test

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
Hemoccult ICT	Hemoccult ICT(formerly FlexSureOBT)	BeckmanCoulter, Inc.	K961062

5.0 Description:

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. It incorporates multiple components including separate sample collection card(s), applicator sticks, test devices, buffer, patient instructions, physician instructions and product instructions for use.

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6.0 Intended Use:

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.

Clinical Significance:

Fecal occult blood tests are useful screening aids for detecting primarily lower gastrointestinal (g.i.) disorders that may be related to iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers or other q.i. lesions that can bleed. Hemoccult ICT is recommended for use by health professionals as part of routine physical examinations or when lower g.i. disorders are suspected.

7.0 Comparison to Predicate(s):

The following tables show the similarities and differences between the predicates identified in Section 4.0 of this summary.

Similarities to the Predicate
Product	Aspect/Characteristic	Comments
Hemoccult ICT	Intended Use	Same as PredicateHOICT
	Composition of Test CardMaterials	Same as PredicateHOICT
	Buffer Solution	Same as PredicateHOICT
	Testing Procedure Methodology	Same as PredicateHOICT
	Sample Stability	Same as PredicateHOICT
	Analytical Performance	Same as PredicateHOICT
	Clinical Performance SourceData	Same as PredicateHOICT

Similarities to the Predicate

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Product	Aspect/Characteristic	Comments
Hemoccult ICT	Clinical Performance DataPresentation	Data provided in the newproduct instructions includesclinical performance for allthree days evaluated duringthe original predicate clinicalstudy.
	2-day Patient ScreeningKit Labeling	A 2-day kit option is beingcreated whereas thepredicate only offered a 3-day kit.
	3-day Patient ScreeningKit Labeling	The predicate PatientScreening Kit Labeling isnow adding thespecifications of being a 3-day kit.

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through intended use, material composition, formulation, and clinical performance data analysis.

Immunochemical fecal occult blood test positivity rates of approximately 2% should be expected in a screening population of average risk, asymptomatic individuals age 50 or older. The Hemoccult ICT was evaluated using multiday fecal collections (all returned collections of the three dispensed slides regardless of number of days), one day fecal collections (day one results only), two day collections (day one and day two results) and three day collections (only those individuals who returned all three days of fecal collections). The positivity rate for multi-day collections was approximately 2% in a group of 88 young, presumed normal volunteers, ages 17-33, who did not follow a restricted diet. The Hemoccult ICT multi-day screening positivity rate and estimated positive predictive value for colorectal neoplasia were 1,8% and 15.6%, respectively, in a group of 1734 average risk individuals, ages 41-97, who followed a restricted diet. Among high risk patients, Hemoccult ICT multi-day screening had a clinical sensitivity of 90% for colorectal cancer and 28% for large adenomas; in this study, Hemoccult ICT had low sensitivity for non-neoplastic colorectal lesions.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wings, representing health, human services, and well-being. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circle's perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2008

Beckman Coulter, Inc. C/O Sylvia Zorich 200 South Kraemer Boulevard, W-110 PO Box 8000 Brea, California 92822

Re: K080812

Trade/Device Name: Hemoccult ICT Regulation Number: 21 CFR 864.6550 Regulation Name: Occult Blood Test Regulatory Class: Class II Product Code: KHE Dated: March 21, 2008 Received: March 24, 2008

Dear Ms. Zorich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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Page 2 - Beckman Coulter, Inc.

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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillancc at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

mckee
for Dr. Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): 10808 | 2

Device Name: Hemoccult® ICT

Indications For Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

Office/of In Witro Diagnostic Device Evaluation and Safety

510(k) K080812

Regulation Number and Section

§ 864.6550 Occult blood test.

(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.