HEMOCCULT ICT

K080812 · Beckman Coulter, Inc. · KHE · Jun 25, 2008 · Hematology

Device Facts

• Record ID: K080812
• Device Name: HEMOCCULT ICT
• Applicant: Beckman Coulter, Inc.
• Product Code: KHE · Hematology
• Decision Date: Jun 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Indications for 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. 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 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 Story

Hemoccult ICT is a rapid, qualitative, visually read immunochemical chromatographic test for human hemoglobin in fecal samples. Components include sample collection cards, applicator sticks, test devices, and buffer. Used by health professionals in clinical settings to screen for lower GI disorders. The test detects occult blood; results assist clinicians in identifying patients requiring further diagnostic evaluation for colorectal neoplasia or other bleeding lesions. Benefits include non-invasive screening for asymptomatic individuals or those with suspected GI pathology.

Clinical Evidence

Clinical evaluation included 1,734 average-risk individuals (ages 41-97) and 88 young volunteers (ages 17-33). In average-risk populations, multi-day screening positivity rate was 1.8% with a 15.6% positive predictive value for colorectal neoplasia. In high-risk patients, clinical sensitivity was 90% for colorectal cancer and 28% for large adenomas; low sensitivity observed for non-neoplastic lesions. Data supports screening utility for asymptomatic individuals age 50 or older.

Technological Characteristics

Immunochemical chromatographic test; qualitative visual readout. Components: sample collection cards, applicator sticks, test devices, buffer. No electronic components, software, or energy sources. Materials and formulation identical to predicate.

Indications for Use

Indicated for use by health professionals as a screening aid for detecting lower gastrointestinal disorders (e.g., iron deficiency anemia, diverticulitis, ulcerative colitis, polyps, adenomas, colorectal cancers) in patients suspected of having lower GI lesions or during routine physical exams.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Hemoccult ICT (formerly FlexSure OBT) (K961062)

Submission Summary (Full Text)

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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: [phone] FAX: [phone]

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 | Docket<br>Number |
|---------------|---------------------------------------------|--------------------------|------------------|
| Hemoccult ICT | Hemoccult ICT<br>(formerly FlexSure<br>OBT) | Beckman<br>Coulter, 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 Predicate<br>HOICT |
| | Composition of Test Card<br>Materials | Same as Predicate<br>HOICT |
| | Buffer Solution | Same as Predicate<br>HOICT |
| | Testing Procedure Methodology | Same as Predicate<br>HOICT |
| | Sample Stability | Same as Predicate<br>HOICT |
| | Analytical Performance | Same as Predicate<br>HOICT |
| | Clinical Performance Source<br>Data | Same as Predicate<br>HOICT |

Similarities to the Predicate

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| Product | Aspect/Characteristic | Comments |
|---------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hemoccult ICT | Clinical Performance Data<br>Presentation | Data provided in the new<br>product instructions includes<br>clinical performance for all<br>three days evaluated during<br>the original predicate clinical<br>study. |
| | 2-day Patient Screening<br>Kit Labeling | A 2-day kit option is being<br>created whereas the<br>predicate only offered a 3-<br>day kit. |
| | 3-day Patient Screening<br>Kit Labeling | The predicate Patient<br>Screening Kit Labeling is<br>now adding the<br>specifications of being a 3-<br>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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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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:

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.

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