(262 days)
The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
The TECHLAB® ASCA-CHEK test is an enzyme-linked immunoassay (ELISA) for the measurement of human anti-S. cerevisiae antibodies in feces as an aid in the diagnosis of Crohn's disease. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. When human ASCA is present in the fecal specimen, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal ASCA is an aid in the diagnosis of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis. This noninvasive diagnostic method is simple to perform and requires only a fecal specimen for the analysis.
Here's an analysis of the provided text regarding the TECHLAB® ASCA-CHEK test, outlining the acceptance criteria and the study that demonstrated its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as clear thresholds (e.g., "sensitivity must be >X%"). Instead, the performance is compared against clinical diagnoses and against a predicate device. The document highlights the sensitivity and specificity values achieved, which implicitly serve as the demonstrated "acceptance" level for this 510(k) submission, aligning with substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate & Clinical Relevance) | Reported Device Performance (ASCA-CHEK) |
|---|---|---|
| Sensitivity for distinguishing CD from Non-CD (including healthy controls, N=353) | Comparable to predicate devices and clinically useful for aiding diagnosis. | 57.0% (95% CI: 48.5 - 65.2%) |
| Specificity for distinguishing CD from Non-CD (including healthy controls, N=353) | Comparable to predicate devices and clinically useful for aiding diagnosis. | 90.5% (95% CI: 85.5 - 94.0%) |
| Sensitivity for distinguishing CD from UC/IBS (N=285) | Comparable to predicate devices and clinically useful for aiding diagnosis. | 57.0% (95% CI: 48.5 - 65.2%) |
| Specificity for distinguishing CD from UC/IBS (N=285) | Comparable to predicate devices and clinically useful for aiding diagnosis. | 86.7% (95% CI: 79.8 - 91.6%) |
| Sensitivity for distinguishing CD from UC/IBS (Pediatric sites only, N=146) | Clinically useful performance in pediatric population. | 48.4% (95% CI: 35.9 - 61.2%) |
| Specificity for distinguishing CD from UC/IBS (Pediatric sites only, N=146) | Clinically useful performance in pediatric population. | 91.5% (95% CI: 82.7 - 96.2%) |
| Positive Percent Agreement (vs. QUANTA Lite ASCA IgG (Serum), N=82) | Similar performance to the recognized predicate device. | 70.0% (95% CI: 53.3 – 82.9%) |
| Negative Percent Agreement (vs. QUANTA Lite ASCA IgG (Serum), N=82) | Similar performance to the recognized predicate device. | 88.1% (95% CI: 73.6 – 95.5%) |
| Overall Percent Agreement (vs. QUANTA Lite ASCA IgG (Serum), N=82) | Similar performance to the recognized predicate device. | 79.3% (95% CI: 69.6 – 86.1%) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set 1 (All 4 Study Sites, including healthy controls): N=353
- Crohn's disease: 142
- Non-Crohn's disease (Ulcerative colitis, irritable bowel syndrome, healthy persons): 211
- Test Set 2 (All 4 Study Sites, excluding healthy controls): N=285
- Crohn's disease: 142
- Ulcerative colitis and irritable bowel syndrome: 143
- Test Set 3 (Pediatric sites only, excluding healthy controls): N=146
- Crohn's disease: 64
- Ulcerative colitis and irritable bowel syndrome: 82
- Test Set 4 (Paired fecal and serum specimens vs. QUANTA Lite ASCA IgG): N=82
- IBD (Crohn's Disease, Ulcerative Colitis): 70 (CD=47, UC=23)
- Other (IBS, Cancer, indeterminant): 7
- Healthy Persons: 5
- Data Provenance: The study was conducted at "four clinical sites" and included a "mixed patient population including both pediatric and adult patients." The document does not specify the country of origin, but given the contact information, it is likely the U.S. The data appears to be retrospective clinical sample collection, where the samples are then tested by the device and compared to existing clinical diagnoses.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document states that the test results were compared to "clinical assessments for disease diagnosis." It does not specify the number of experts, nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, for a diagnosis of Crohn's disease, it is generally established by gastroenterologists, often involving endoscopy, biopsy, and imaging, implying that the "clinical assessments" would be from qualified medical specialists.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by "clinical assessments for disease diagnosis." This suggests that the clinical diagnosis, as determined by the treating physicians at the four clinical sites, was directly used as the ground truth without a separate adjudication panel for the study itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is an in-vitro diagnostic (IVD) device study comparing the performance of an assay to clinical diagnosis and a predicate assay, not assessing how human readers improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone (algorithm only) performance study. The TECHLAB® ASCA-CHEK test is an ELISA assay; its performance is measured directly from the assay results compared to the clinical ground truth, without human-in-the-loop interaction with the device's analytical output. The "algorithm" here refers to the biochemical process and readout of the ELISA.
7. The Type of Ground Truth Used
The primary type of ground truth used was clinical diagnosis. This clinical diagnosis encompasses a broader assessment including potentially pathology, imaging, patient history, and symptomology, as determined by medical professionals. For the comparison with the predicate device, the predicate device's results (performed on serum) also served as a comparative "ground truth" to assess concordance.
8. The Sample Size for the Training Set
The document does not specify a separate training set. In the context of IVD device submissions, the performance data presented typically relates to the validation of the finalized device (the test set). If internal development or optimization involved training, that information is not provided in this summary.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is described, the method for establishing its ground truth is also not mentioned.
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K 051927
510(k) SUMMARY OF THE TECHLAB® ASCA-CHEK TEST 6.0
| Contact Information | David M.Lyerly |
|---|---|
| Vice-President, Research & Development | |
| TECHLAB®, Inc. | |
| 2001 Kraft Drive | |
| Corporate Research Center | |
| Blacksburg, VA 24060-6364 | |
| Phone: 540-953-1664 | |
| FAX: 540-953-1665 | |
| Email: dlyerly@techlab.com | |
| Date Prepared | March 31, 2006 |
Product and Trade Name TECHLAB® ASCA-CHEK
Predicate Devices
- QUANTA Lite™ ASCA IgG (K000732). This is an ELISA for the semi-quantitative . detection of anti-Saccharomyces cerevisiae IgG antibodies (ASCA) in human serum as an aid for the differential diagnosis of Crohn's disease from ulcerative colitis.
- . QUANTA Lite™ ASCA IgA (K000733). This is an ELISA for the semi-quantitative detection of anti-Saccharomyces cerevisiae IgA antibodies (ASCA) in human serum as an aid for the differential diagnosis of Crohn's disease from ulcerative colitis.
- . ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgG (K032850). An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of anti-Saccharomyces cerevisiae (IgG) in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
- . ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA (K032860), An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of anti-Saccharomyces cerevisiae (IgA) in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
Intended Use
The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.
Device Description
The TECHLAB® ASCA-CHEK test is an enzyme-linked immunoassay (ELISA) for the measurement of human anti-S. cerevisiae antibodies in feces as an aid in the diagnosis of Crohn's disease. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. When human ASCA is present in the fecal specimen, the specific immunoglobulins bind to the S. cerevisiae antigens that are immobilized in the test well. Following this binding step, the polyvalent anti-human
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horseradish peroxidase (HRP) conjugate binds to the ASCA and reacts with the substrate to produce a positive result. The measurement of fecal ASCA is an aid in the diagnosis of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis. This noninvasive diagnostic method is simple to perform and requires only a fecal specimen for the analysis.
| Test | Description | Format | Turn-around time | Limitations |
|---|---|---|---|---|
| TECHLAB®ASCA-CHEK | Intended fordetermining thepresence of fecalantibodies againstS. cerevisiae(ASCA antibodies)in adult andpediatric IBD andIBS patients as anaid in the diagnosisof Crohn's disease. | ELISA | 75 minutes | ASCA are found inabout 50 to 60% ofpersons with Crohn'sdisease. The two-stepELISA procedurerequires multiple washsteps. The test doesnot identify all personswith Crohn's disease. |
| QUANTA Lite™ASCA(S. cerevisiae) IgGELISA (K000732) | Intended fordetermining thepresence of serumantibodies againstS. cerevisiae(ASCA antibodies)in adult IBDpatients | ELISA | 90 minutes | ASCA serumantibodies are found inabout 50 to 60% ofpersons with Crohn'sdisease. The test doesnot identify all personswith Crohn's disease. |
| QUANTA Lite™ASCA(S. cerevisiae) IgAELISA (K000733) | Intended fordetermining thepresence of serumantibodies againstS. cerevisiae(ASCA antibodies)in adult IBDpatients | ELISA | 90 minutes | ASCA serumantibodies are found inabout 50 to 60% ofpersons with Crohn'sdisease. The test doesnot identify all personswith Crohn's disease. |
| ImmuLisa Anti-SaccharomycesAntibody (ASCA)IgG (K032850) | Intended fordetermining thepresence of serumantibodies againstS. cerevisiae(ASCA antibodies)in IBD patients | ELISA | 90 minutes | ASCA serumantibodies are found inabout 50 to 60% ofpersons with Crohn'sdisease. The test doesnot identify all personswith Crohn's disease. |
| ImmuLisa Anti-SaccharomycesAntibody (ASCA)IgA (K032860) | Intended fordetermining thepresence of serumantibodies againstS. cerevisiae(ASCA antibodies)in IBD patients | ELISA | 90 minutes | ASCA serumantibodies are found inabout 50 to 60% ofpersons with Crohn'sdisease. The test doesnot identify all personswith Crohn's disease. |
Comparative information of equivalent devices
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Summary of Performance Data
When comparing the ASCA-CHEK test results for all 4 Study Sites to clinical assessments for disease diagnosis including the healthy controls (N=353), the sensitivity for distinguishing Crohn's disease from ulcerative colitis, irritable bowel syndrome and healthy persons was 57% and the specificity was 91%.
Statistical analysis of the ASCA-CHEK test results compared to clinical diagnosis for Crohn's disease, ulcerative colitis and irritable bowel syndrome, and from healthy persons.
| N=353 | Crohn's disease | Non-Crohn'sdisease | Total |
|---|---|---|---|
| ASCA-CHEK test Positive | 81 | 20 | 101 |
| ASCA-CHEK test Negative | 61 | 191 | 252 |
| Total | 142 | 211 | 353 |
| 95% Confidence Intervals | ||
|---|---|---|
| Sensitivity | 57.0% | 48.5 - 65.2% |
| Specificity | 90.5% | 85.5 - 94.0% |
| Predicted Positive Value | 80.2% | 70.8 - 87.2% |
| Predicted Negative Value | 75.7% | 69.9 - 80.9% |
| Correlation | 77.1% | 72.5 - 81.0% |
| Negative Value | 75.7% | 69.9 – 80.9% |
|---|---|---|
| 77.1% | 72.5 – 81.0% |
When comparing the ASCA-CHEK test results for all 4 sites to clinical assessments for disease diagnosis excluding healthy controls (N=285), the sensitivity for distinguishing Crohn's disease from ulcerative colitis and irritable bowel syndrome was 57% and the specificity was 87%.
Statistical analysis of the ASCA-CHEK test results compared to the clinical diagnosis for Crohn's disease, ulcerative colitis and irritable bowel syndrome.
| N=285 | Crohn's disease | Ulcerative colitis and irritable bowel syndrome |
|---|---|---|
| ASCA-CHEK test Positive | 81 | 19 |
| ASCA-CHEK test Negative | 61 | 124 |
| 95% Confidence Intervals | ||
| Sensitivity | 57.0% | 48.5 - 65.2% |
| Specificity | 86.7% | 79.8 - 91.6% |
| Predicted Positive Value | 81.0% | 71.7 - 87.9% |
| Predicted Negative Value | 67.0% | 59.7 - 73.7% |
| Correlation | 71.9% | 65.8 - 77.0% |
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Summary of Performance Data (cont'd)
Correlation
When comparing the ASCA-CHEK test results for both pediatric sites to clinical assessments for disease diagnosis excluding healthy controls (N=146), the sensitivity for distinguishing Crohn's disease from ulcerative colitis and irritable bowel syndrome was 48% and the specificity was 92%.
| Statistical analysis of the ASCA-CHEK test results compared to the clinical diagnosis | |||
|---|---|---|---|
| for Crohn's disease, ulcerative colitis and irritable bowel syndrome. |
| N=146 | Crohn's disease | Ulcerative colitis andirritable bowel syndrome | |
|---|---|---|---|
| ASCA-CHEK test Positive | 31 | 7 | |
| ASCA-CHEK test Negative | 33 | 75 | |
| 95% Confidence Intervals | |||
| Sensitivity | 48.4% | 35.9 - 61.2% | |
| Specificity | 91.5% | 82.7 - 96.2% | |
| Predicted Positive Value | 81.6% | 65.1 - 91.7% | |
| Predicted Negative Value | 69.4% | 59.7 - 77.8% |
72.5%
The ASCA-CHEK test was tested at four clinical sites and included a mixed patient population including both pediatric and adult patients. The table below shows the comparison of clinical sensitivity and specificity for fecal ASCA in pediatric and adult patient populations. There was no difference observed in clinical performance of the ASCA-CHEK test between pediatric and adult patients. The table below shows a summary of the ASCA-CHEK test results between the four clinical sites,
Four clinical site study *:
63.9 - 79.4%
| Site 1 | Site 2 | Site 3 | Site 4 | |
|---|---|---|---|---|
| Pediatric:n=78 | Adult:n=107 | Pediatric:n=23 | Ped. andAdult:n=82 | |
| Sensitivity | 40.0% | 63.3% | 54.5% | 63.8% |
| Specificity | 88.5% | 81.1% | 91.7% | 91.4% |
*Total n=290 (Excludes the 53 healthy adults)
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Summary of results for the ASCA-CHEK test and the OUANTA™ Lite tests using paired fecal and serum specimens
The ASCA-CHEK and QUANTA™ Lite tests showed similar results in all categories with the ASCA-CHEK test showing a total of 64% positive results for subjects with CD compared to 77% positive for the QUANTA™ Lite test. The results for the different categories are shown in the table below.
| Clinical AssessmentsN = 82 | Total #ofpatients | ASCA-CHEKFecal Positiveresult | QUANTA™ LiteSerum Positiveresults |
|---|---|---|---|
| Total IBD | 70 | 31 (44%) | 37 (53%) |
| Total Crohn's Disease | 47 | 30 (64%) | 36 (77%) |
| Total Ulcerative Colitis | 23 | 1 (4%) | 1 (4%) |
| Total Other: IBS,Cancer, indeterminant | 7 | 1 (14%) | 1 (14%) |
| Total Healthy Persons | 5 | 1 (20%) | 2 (40%) |
When comparing the ASCA-CHEK test results done in feces compared to the QUANTA Lite™ ASCA IgG test performed in serum for paired specimens (fecal/serum) collected from both pediatric and adult sites (N=82), the positive percent agreement was 70% and the negative percent agreement was 88%.
Statistical analysis of the ASCA-CHEK test results compared to the clinical diagnosis for Crohn's disease, ulcerative colitis and irritable bowel syndrome.
| N=82 | QUANTA Lite™ASCA IgG SerumtestPositive | QUANTA Lite™ASCA IgGSerum testNegative | Total |
|---|---|---|---|
| ASCA-CHEK test Positive | 28 | 5 | 33 |
| ASCA-CHEK test Negative | 12 | 37 | 49 |
| Total | 40 | 42 | 82 |
95% Confidence Intervals
| Percent Positive Agreement | 70.0% | 53.3 – 82.9% |
|---|---|---|
| Percent Negative Agreement | 88.1% | 73.6 – 95.5% |
| Overall Percent Agreement | 79.3% | 69.6 – 86.1% |
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Based on these findings, we believe the ASCA-CHEK test is substantially equivalent to other diagnostic tests now used to evaluate patients suspected of having inflammatory bowel disease. Further, our results demonstrate that the ASCA-CHEK test is suitable as an in vitro diagnostic aid to help identify patients with Crohn's disease when assessing patients with chronic intestinal illnesses.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 2006 APR
TECHLAB, Inc. c/o David M. Lyerly, Ph.D. Vice President, Research & Development 2001 Kraft Drive Corporate Research Center Blacksburg, VA 24060-6364
Re: K051927
Trade/Device Name: TECHLAB® ASCA-CHEK Regulation Number: 21 CFR 866.5785 Regulation Name: Anti-Saccharomyces cerevisiae (ASCA) Test System Regulatory Class: Class II Product Code: NBT Dated: July 15, 2005 Received: July 18, 2005
Dear Dr. Lyerly:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0484. 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 Division 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/industry/support/index.html.
Sincerely yours,
Robert L. Backing
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 2.
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings.
FOR IN VITRO DIAGNOSTIC USE.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
and the same of the same of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the sta
(21 CFR 801 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)
- Nena Chan
Sision Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 866.5785 Anti-
Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test systems.(a)
Identification. The Anti-Saccharomyces cerevisiae (S. cerevisiae ) antibody (ASCA) test system is an in vitro diagnostic device that consists of the reagents used to measure, by immunochemical techniques, antibodies toS. cerevisiae (baker's or brewer's yeast) in human serum or plasma. Detection ofS. cerevisiae antibodies may aid in the diagnosis of Crohn's disease.(b)
Classification. Class II (special controls). The special control is FDA's “Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae ) Antibody (ASCA) Premarket Notifications.”