(224 days)
The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
The FOB One Step Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the double antibody-sandwich technique. The membrane is pre-coated with anti-hemoglobin antibody on the test line region of the device. During testing, the specimen reacts with the particle coated with anti-hemoglobin antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hemoglobin antibody on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text, focusing on the acceptance criteria and study details for the Orient Gene Biotech - One Step Rapid FOB device:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not explicitly stated as clear, pre-defined thresholds. Instead, the study aims to demonstrate performance that is comparable to, or meets expected results. I've inferred the expected performance based on the wording.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Detection Limit (Sensitivity): Expected to detect 50 ng hHb/mL and higher. | 50 ng hHb/mL: 100% positive (20/20 samples) |
| 62.5 ng hHb/mL: 100% positive (20/20 samples) | |
| 2000 ng hHb/mL: 100% positive (20/20 samples) | |
| 0 ng hHb/mL: 0% positive (0/20 samples) | |
| 37.5 ng hHb/mL: 0% positive (0/20 samples) | |
| No Pro-zone Effect: No false negatives at high concentrations. | No pro-zone effect seen up to 2000 ng hHb/ml. |
| Inter-Site Reproducibility: Consistent results across different sites and lots. | All 45 samples for 50, 62.5, and 2000 ng/mL hHb concentrations were positive across 3 sites and 3 lots. All 45 samples for 0 and 37.5 ng/mL hHb concentrations were negative. |
| Intra-Run Reproducibility: Consistent results within a single run. | All 30 samples for 50, 62.5, and 2000 ng/mL hHb concentrations were positive across 3 lots. All 30 samples for 0 and 37.5 ng/mL hHb concentrations were negative. |
| Inter-Day Reproducibility: Consistent results across different days. | All 30 samples for 50, 62.5, and 2000 ng/mL hHb concentrations were positive across 3 days. All 30 samples for 0 and 37.5 ng/mL hHb concentrations were negative. |
| Accuracy (Technical Personnel): High agreement with expected and predicate device results. | 99.0% agreement with expected results (for 3 sites). 98.0% agreement with predicate device results (for 3 sites). |
| Accuracy (Non-Technical Personnel - Layuser): High agreement with expected and predicate device results. | 98.7% agreement with expected results (Orient Gene FOB Test Layuser vs. Expected). 98.0% agreement with predicate device results (Orient Gene FOB Test Layuser vs. Predicate test). |
| Percent Positive Agreement (Technical Personnel vs. Predicate): High agreement for positive samples. | 98.3% (95% C.I. = 91.1% - 100%) |
| Percent Negative Agreement (Technical Personnel vs. Predicate): High agreement for negative samples. | 97.5% (95% C.I. = 86.8% - 99.9%) |
| Overall Agreement (Technical Personnel vs. Predicate): High overall agreement. | 98.0% (95% C.I. = 93.0% - 99.8%) |
| Potential Interferences: No significant interference from tested substances. | Interference study carried out, no adverse results explicitly stated, implying no significant interference. |
| Potential Cross Reactors: No false positives from animal hemoglobin. | No reaction from various animal hemoglobins at 200 ng/mL. |
2. Sample Size Used for the Test Set and Data Provenance
- Detection Limit: 100 hemoglobin-free stool samples were used, spiked with varying concentrations (divided into groups of 20 for each concentration level). Data provenance is not specified (e.g., country of origin), but it appears to be lab-based, likely retrospective as samples were spiked.
- Potential Interferences: Not specified, but involved aqueous fecal samples. Likely retrospective (lab-prepared).
- Potential Cross Reactors: Not specified, but involved negative and positive fecal samples spiked with animal hemoglobin. Likely retrospective (lab-prepared).
- Reproducibility (Inter-Site): 75 hemoglobin-free fecal samples (split into groups for each concentration, 15 per group, tested 5 times each lot).
- Reproducibility (Intra-Run): 50 hemoglobin-free fecal samples (split into groups, 10 per group, tested 10 times each).
- Reproducibility (Inter-Day): 50 fecal samples (split into groups, 10 per group, tested 10 replicates each day for 3 days).
- Accuracy (Technical Personnel): 100 human stool extraction samples (20 replicates at each concentration). Data provenance is not specified, but the study was conducted at "three physician office laboratories." This suggests prospective collection or preparation of samples for this specific study.
- Accuracy (Non-Technical Personnel): 150 human stool extraction samples (30 at each concentration). Data provenance is not specified, but the study was conducted in a "medical laboratory." This also suggests prospective collection or preparation for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- For the Detection Limit, Reproducibility, Interference, and Cross-Reactivity studies, the ground truth was established by spiking known concentrations of human hemoglobin (or other substances) into hemoglobin-free fecal samples. This means the known concentration of the analyte served as the ground truth. No human experts were explicitly stated to establish this ground truth, as it was a controlled, experimental setup.
- For the Accuracy studies, the "expected results" for the spiked samples also served as a ground truth (i.e., whether the spiked concentration should result in a positive or negative test). Additionally, the predicate device was used as a comparative "ground truth" or reference standard. No specific number or qualifications of experts are given for establishing the "expected results" for spiked samples, as these are inherent to the experimental design.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for most studies was established by the known concentrations of spiked analytes. For the accuracy study, comparisons were made against "expected results" (based on spiking) and the predicate device. There was no mention of an adjudication process by multiple human observers to establish a consensus ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the traditional sense of evaluating human readers' diagnostic accuracy with and without AI assistance. This device is a rapid diagnostic test kit, not an AI imaging or diagnostic algorithm.
The "Accuracy" section does compare the new device's performance when used by both "technical personnel" and "non-technical personnel" (layusers) against the predicate device. This is a form of comparative effectiveness, but it's evaluating the device itself and its usability by different user groups, rather than the effect of AI assistance on human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the device itself, being a rapid diagnostic test, operates in a standalone manner. The results are interpreted visually (presence or absence of a colored line). While human users read the result, the "performance characteristics" (detection limit, reproducibility, interference, cross-reactivity) are essentially standalone performance evaluations of the device's ability to react to specific analyte concentrations. The "Accuracy" studies then evaluate human interpretation of these standalone device results.
7. The Type of Ground Truth Used
The primary type of ground truth used was known concentrations of spiked human hemoglobin (hHb) in hemoglobin-free fecal samples. This is a form of analytically defined ground truth or experimental ground truth. For the accuracy studies, the predicate device's results also served as a comparative ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a rapid chromatographic immunoassay, not an AI or machine learning algorithm that requires a "training set" in the computational sense. The device's components (antibodies, membrane, etc.) are manufactured based on established biochemical principles and quality control, not trained on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K110309
| Submitted By: | Zhejiang Orient Gene Biotech Co., LTDJi'er Road, Jiankang Industrial Area (Medicine),Anji Economic Development Zone, Zhejiang, China, 313300 |
|---|---|
| Tel: +86-572-5226111 E-mail:sales@orientgene.comFax: +86-572-5226222 Web site: www.orientgene.com | |
| Official Correspondent: | Gary LehnusLehnus & Associates Consulting |
| Telephone | (570) 620-0198 |
| FAX | (570) 620-0199 |
| Date Prepared: | January 28, 2011 |
| Device Name | Trade or Proprietary Name: Orient Gene Biotech - One Step Rapid FOBCommon or Usual Name: Fecal Occult Blood Test. |
| Regulation | 21 CFR 864.6550 |
| Classification | Class II |
| Product Codes | KHE |
| Panel: | Hematology |
| Predicate Device: | K070660 - INSTANT-VIEW® Fecal Occult Blood (FOB) Rapid Test |
| Device Description | The FOB One Step Rapid Test is a lateral flow chromatographicimmunoassay based on the principle of the double antibody-sandwichtechnique. The membrane is pre-coated with anti-hemoglobin antibody onthe test line region of the device. During testing, the specimen reacts withthe particle coated with anti-hemoglobin antibody. The mixture migratesupward on the membrane chromatographically by capillary action to reactwith anti-hemoglobin antibody on the membrane and generate a coloredline. The presence of this colored line in the test region indicates a positiveresult, while its absence indicates a negative result. To serve as aprocedural control, a colored line will always appear in the control line regionindicating that proper volume of specimen has been added and membranewicking has occurred. |
| Intended Use | The FOB One Step Rapid Test is a rapid chromatographic immunoassay forthe qualitative detection of human occult blood in human fecal specimens. |
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The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
Indications for Use The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for Over the Counter Use.
SUBSTANTIAL EQUIVALENCE
The following tables summarize similarities and differences between FOB One Step Rapid Test and the current INSTANT-VIEW® Fecal Occult Blood (FOB) Rapid Test.
| Item | INSTANT-VIEW® Fecal Occult Blood(FOB) Rapid Test Predicate | FOB One Step Rapid Test |
|---|---|---|
| Intended Use | The Instant-View® Fecal OccultBlood (FOB) Rapid Test is a rapidqualitative test for theimmunochemical detection of fecaloccult blood/human hemoglobin(hHb) in human fecal specimens asan aid in the diagnosis ofgastrointestinal disorders such as:diverticulitis, colitis, polyps, andcolorectal cancer. The device issuitable for use in laboratories andphysician's offices as well as forhome use. | The FOB One Step Rapid Test is arapid chromatographicimmunoassay for the qualitativedetection of human occult blood inhuman fecal specimens as anaid in the diagnosis ofgastrointestinal disorders suchas: diverticulitis, colitis, polyps,and colorectal cancer. Thedevice is suitable for use inlaboratories and physician'soffices as well as for Over theCounter use. |
| Specimen | Fecal | Same |
| Sensitivity | 0.05 µg hHb/mL | Same -50 ng hHb/mL |
| Storage | 2 - 30°C | Same |
| Principle | Sandwich ImmunochromatographicAssay | Same |
| Read Time | 5 Minutes | 5 minutes |
| Test Line | Membrane Immunoassay | Colloidal Gold |
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Performance Characteristics
The following are performance characteristics of FOB One Step Rapid Test
Detection limit:
The sensitivity of the device was tested by spiking 100 hemoglobin-free stool samples with varying concentrations (0, 37.5, 50, 62.5 and 2000ng hHb/ml) of human hemoglobin. The test shows a cutoff of 50ng hHb/mL of buffer solution and no pro-zone effect was seen up to 2000 ng hHb/ml of buffer solution. Result are summarized below:
| hHb concentration(ng/mL) | Total | Positive | Negative |
|---|---|---|---|
| 0 | 20 | 0 | 20 |
| 37.5 | 20 | 0 | 20 |
| 50. | 20 | 20 | 0 |
| 62.5 | 20 | 20 | 0 |
| 2000 | 20 | 20 | 0 |
Potential Interferences
An interference study was carried out by adding known amounts of potential interfering substances to aqueous fecal samples that contain 0 and 50 ng /mL of human hemoglobin. Substances tested included horseradish peroxidase (20 mg/mL), aqueous extracts of red radish, raw turnip, cauliflower and broccoli, dietary supplements of chloride, Vitamin C (ascorbic acid) and iron, and toilet water with and without cleaner and deodorizer.
Potential Cross Reactors:
A cross-reactivity study of animal hemoglobin was carried out by spiking negative(0 ng hHb /mL) and positive(50 ng hHb /mL) fecal samples with no reaction from beef hemoglobin, chicken hemoglobin, fish hemoglobin, horse hemoglobin, goat hemoglobin, pig hemoglobin, rabbit hemoglobin and sheep hemoglobin, respectively, at the concentration of 200 na/mL.
REPRODUCIBILITY
Inter-Site
To evaluate reproducibility of the test, 75 hemoglobin-free fecal samples spiked with varying levels (0. 37.5. 50. 62.5. and 2000 ng hHd/mL) of human hemoglobin were tested at 3 medical laboratories with 3 lots of tests and run 5 times each lot at each site. The results are summarized below:
| 3 Sites | TotalResults | Lot 1 | Lot 2 | Lot 3 |
|---|---|---|---|---|
| Hb concentrations | P / N | P / N | P / N | |
| 0 ng/mL | 45 | 0 / 15 | 0 / 15 | 0 / 15 |
| 37.5 ng/mL | 45 | 0 / 15 | 0 / 15 | 0 / 15 |
| 50 ng/mL | 45 | 15 / 0 | 15 / 0 | 15 / 0 |
| 62.5 ng/mL | 45 | 15 / 0 | 15 / 0 | 15 / 0 |
| 2,000 ng/mL | 45 | 15 / 0 | 15 / 0 | 15 / 0 |
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Intra-Run
Intra-Run reproducibility was determined by testing 3 lots of test cassettes by spiking 50 hemoglobin-free fecal samples with varying levels(0, 37.5, 50, 62.5, and 2000 ng hHg/ml) of human hemoglobin and run 10 times each. The results are summarized below:
| TotalResults | Lot 1 | Lot 2 | Lot 3 | |
|---|---|---|---|---|
| Hb concentrations | P / N | P / N | P / N | |
| 0 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 37.5 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 50 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 62.5 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 2,000 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
Inter-Day
Day to day reproducibility study was carried out by testing cassettes from the same lot with 50 fecal samples spiked with varying levels (0, 37.5, 50, 62.5, and 2000 ng hHg/ml) of human hemoglobin on 3 consecutive days with 10 replicates each day. The results are summarized below:
| 3 days | Total Results | Lot 1 | Lot 2 | Lot 3 |
|---|---|---|---|---|
| Hb concentrations | P / N | P / N | P / N | |
| 0 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 37.5 ng/mL | 30 | 0 / 10 | 0 / 10 | 0 / 10 |
| 50 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 62.5 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
| 2,000 ng/mL | 30 | 10 / 0 | 10 / 0 | 10 / 0 |
ACCURACY
A study was conducted to evaluate the Fecal Occult Blood Rapid Test and compare results with a commercially available Fecal Occult Blood Rapid Test at three physician office laboratories by technical personnel, and one medical laboratory by non-technical personnel with diverse educational backgrounds and ages.
Consumer results using the FOB One Step Rapid Test compared to both the professional and Predicate test results were evaluated:
Study of technical personnel
In each POL site, 100 human stool extraction samples were spiked with human hemoglobin at the following concentrations: 0, 37.5, 50, 62.5, and 500 ng/ml (20 replicates at each concentration). Results obtained from 3 sites agreed 99.0% with the expected results and 98.0% with results of predicated device.
Study of non-technical personnel
150 human stool extraction samples were spiked with hHb at the following concentrations: 0. 37.5, 50, 62.5, and 500ng/ml (30 at each concentration). Thirty (30) participants without technical background were enrolled to conduct the study in a medical laboratory. Each participant tested 5 samples (1 at each concentration) with the two FOB devices.
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| Tests (tester) | TotalEvaluatedSamples | CorrectResults | DiscrepantResults | Agreement |
|---|---|---|---|---|
| Orient Gene FOB TestLayuser vs. Expected | 150 | 148 | 2 | 98.7% |
| Orient Gene FOB TestLayuser vs. Predicate test | 150 | 147 | 3 | 98.0% |
| Orient Gene FOBtechnicians vs Expected | 100 | 99 | 1 | 99.0% |
| Orient Gene FOBTechnician vs Predicatetest | 100 | 98 | 2 | 98.0% |
Results generated by 3 trained technicians with the Orient Gene FOB One Step Rapid Test as compared to the predicate test:
| Predicate test | Total Results | ||||
|---|---|---|---|---|---|
| Orient | Gene | Results | Positive | Negative | |
| FOB Test | Positive | 59 | 1 | 60 | |
| Negative | 1 | 39 | 40 | ||
| Total Results | 60 | 40 | 100 |
Percent Positive Agreement = 59/60 = 98.3% (95% C.1. = 91.1% - 100%) Percent Negative Agreement = 39/40 = 97.5% (95% C.I. = 86.8% - 99.9%) Overall Agreement = 98/100= 98.0% (95% C.I. = 93.0% - 99.8%)
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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The eagle is positioned to the right of the seal's center. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Orient Gene Biotech c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
SEP 1 4 2011
Re: K110309
Trade/Device Name: FOB One Step Rapid Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: July 5, 2011 Received: July 27, 2011
Dear Mr. Lehnus:
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 class II (Special Controls), 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and 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 described in your Section 510(k) premarket notification. The FDA finding of
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Page 2 - Mr. Gary Lehnus
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 Parts 801 and 809). please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
ြင္း
Ravi Philip
Maria M. Chan, 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
510(k) Number (if known): K110309
Device Name: _________ FOB One Step Rapid Test
Indications For Use:
The FOB One Step Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human occult blood in human fecal specimens. The device is suitable for use in laboratories and physician's offices as well as for home use.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KIID309 510(k)
Page 1 of 1
§ 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.