(97 days)
The Hemosure™ One-Step Fecal Occult Blood (FOB) Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determine gastrointestinal (GI) bleeding found in a number of GI disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
The Hemosure™ One-Step FOB Test is a lateral flow immunoassays intended for the detection of fecal occult blood.
Here's a breakdown of the acceptance criteria and study details for the Hemosure™ One-Step Fecal Occult Blood (FOB) Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Sensitivity | |
| Detect human hemoglobin at 50 ng hHb/mL | 100% positive results for samples ≥ 50 ng hHb/mL |
| Specificity/Non-interference | |
| No interference from dietary substances | Stated: "Neither dietary substances nor toilet water fresheners or cleansers interfere" |
| No interference from toilet water | Stated: "Neither dietary substances nor toilet water fresheners or cleansers interfere" |
| No cross-reactivity with non-human hemoglobin | Stated: "does not cross-react with hemoglobin from other species." |
| Positive results only for human hemoglobin | Stated: "gives positive results only when human hemoglobin with sufficient concentration is present." |
| Overall Accuracy | |
| N/A (implied high agreement with expected results) | Overall accuracy: 98% |
| Agreement with predicate device (for sensitivity) | 100% agreement with predicate device (for sensitivity at concentrations ≥ 50 ng hHb/mL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sensitivity Test Set:
- Sample Size: 50 extracted stool samples.
- Data Provenance: "collected in house" - implies internal to WHPM, Inc. Retrospective, as samples were collected and then spiked.
- Overall Accuracy Test Set:
- Sample Size: 100 extracted stool samples.
- Data Provenance: "collected in house" - implies internal to WHPM, Inc. Retrospective, as samples were collected and then spiked.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish the ground truth for the test set. Instead, the ground truth was established by spiking known concentrations of human hemoglobin into negative stool samples.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The ground truth was established by direct spiking of known concentrations of human hemoglobin. The "expected results" were based on these known concentrations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study involved testing the device at different laboratories (physician's office, reference laboratory, WHPM Inc. laboratory), which suggests multiple readers, but it does not detail a comparison of human readers with vs. without AI assistance. This is a diagnostic device, not an AI-assisted diagnostic tool.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study
Yes, a standalone study was performed. The device, an immunoassay, is designed to be read directly. The "studies were performed in three sites" and "tested with the Hemosure™ One-Step FOB Test" directly, meaning the device's performance itself was evaluated against known ground truth without human interpretive assistance being measured as a variable.
7. Type of Ground Truth Used
The ground truth used was known concentrations of spiked human hemoglobin (hHb) in stool samples that were initially free of human hemoglobin. This is an engineered ground truth for analytical performance rather than a clinical ground truth from patient outcomes or pathology.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. For an immunoassay device, the "training" typically refers to the development and optimization of the assay itself, rather than training a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
As no specific training set for an algorithm is mentioned, this question is not directly applicable. For the device's development/optimization, the ground truth would likely have been established through controlled experiments with known concentrations of analytes, similar to how the test set's ground truth was established.
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510(k) Submission Hemosure™ One-Step Fecal Occult Blood (FOB) Test WHPM, Inc.
K04/202
Page 24 of 38
AUG 1 2 2004
510 (k) Summary
Date of Summary: 5 May 2004
Product Name
Hemosure™ One-Step Fecal Occult Blood (FOB) Test
Sponsor and Manufacturer
WHPM. Inc. 9440 Telstar Avenue, Unit 1 El Monte, CA 91731
Correspondent
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Devices
Manufacturer: Alfa Scientific Designs, Inc. Instant-View Fecal Occult Blood (FOB) II Test (Cassette). Product:
Product Description
The Hemosure™ One-Step FOB Test is a lateral flow immunoassays intended for the detection of fecal occult blood.
Intended Use
The Hemosure™ One-Step Fecal Occult Blood (FOB) Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determine gastrointestinal (GI) bleeding found in a number of GI disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
Performance Characteristics
Neither dietary substances nor toilet water fresheners or cleansers interfere with the Hemosure™ One-Step FOB Test.
The Hemosure™ One-Step FOB Test gives positive results only when human hemoglobin with sufficient concentration is present. The Hemosure™ One-Step FOB Test does not crossreact with hemoglobin from other species.
Fifty extracted stool samples, free of human hemoglobin, were collected in house and then spiked with human hemoglobin (hHb) to the following concentrations: 0ng hHb/mL, 37.5ng hHb/mL (25% lower than cutoff), 50ng hHb/mL (cutoff), 62.5ng hHb/mL (25% higher than cutoff), and 2,000ng hHb/mL. All samples with concentrations of 50 ng hHb/mL or greater gave positive results. The results agreed 100% with predicate device. This indicates
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510(k) Submission Hemosure™ One-Step Fecal Occult Blood (FOB) Test WHPM, Inc.
Page 25 of 38
Hemosure™ One-Step FOB Test has a sensitivity of 50 ng hHb/mL. 100 extracted stool samples, free of human hemoglobin, were collected in house and then spiked with human hemoglobin (hHb) to the following concentrations: 0ng hHb/mL, 37.5ng hHb/mL (25% lower than cutoff), 50ng hHb/mL (cutoff), 62.5ng hHb/mL (25% higher than cutoff), and 2,000ng hHb/mL. The samples were then blinded and tested with the Hemosure™ One-Step FOB Test. The studies were performed in three sites including a physician's office laboratory, a reference laboratory, and the W.H.P.M. Inc. laboratory. The test results obtained from Physician's Office Laboratory agreed 97% with the expected results. The results obtained from the Reference Laboratory and W.H.P.M., Inc.'s Laboratory both agreed 99% with the expected results. Accordingly, the overall accuracy of the Hemosure One-Step Fecal Occult Blood Test is 98%.
Conclusion
The Hemosure™ One-Step FOB Test is substantially equivalent to Alfa Scientific Designs' Instant-View Fecal Occult Blood (FOB) II Test.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo. The logo is a stylized image of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
W.H.P.M., Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915
AUG 1 2 2004
K041202 Re:
R041202
Trade/Device Name: Hemosure™ One-Step Fecal Occult Blood Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: July 13, 2004 Received: July 14, 2004
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave leviewed your beetier broom processorially equivalent (for the indications for use stated in the above and have devices marketed predicate devices marketed in interstate commerce prior to May 28, 1976, Che enactment date of the Medical Device Amendments, or to devices that have been reclassified in the chacmient date of the Frederal Food, Drug, and Cosmetic Act (Act) that do not require accordation with the provisions of molication (PMA). You may, therefore, market the device, subject to approval of a provisions of the Act. The general controls provisions of the Act include the general coff. 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 IT your device is elassified (oo as e vy isting major regulations affecting your device can be found in Title Subject to suen architens (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 I loase of artistion that your device complies with other requirements of the Act or any Federal statues and regulations administered by other Federal agencies. You must comply with all the t carrar states and regarding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 Acr 3 requirements, movements as a good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as (Qurregulation (Section 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 information about the application of labeling requirements to your device, rr you atons on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).
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Page 2
If you desire specific information about the application of labeling requirements to your device, r you don't on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the rou may other of Small Manufacturers, International and Consumer 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
K041202 510(k) Number:
Hemosure™ One-Step Fecal Occult Blood Test Device Name:
Indication for Use:
The Hemosure™ One-Step Fecal Occult Blood (FOB) Test is an immunochemical device intended for the qualitative detection of Fecal Occult Blood by laboratories or physicians offices. It is useful to determine gastrointestinal (GI) bleeding found in a number of GI disorders, e.g. diverticulitis, colitis, polyps, and colorectal cancer.
For professional use only.
Prescription Use >< (21 CFR 801 Subpart D)
AND/OR
Over The Counter Use _________________________________________________________________________________________________________________________________________________________ (21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041202
§ 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.