The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. 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 ASCA-CHEK test is an ELISA for the measurement of human anti-S. cerevisiae antibodies in feces and serum as an indicator of Crohn's disease in combination with other clinical and laboratory findings. The assay utilizes antigens of S. cerevisiae for capture and a polyvalent anti-human immunoglobulin conjugate. For feces, a specimen dilution of 1:10 and an OD 450 cut-off ≥0.150 or OD450620 ≥0.110 are used for the analysis. For serum, a specimen dilution of 1:1000 and an OD450 cut-off ≥0.110 or OD450620 ≥0.080 are used for the analysis. When human ASCA is present in fecal or serum specimens, 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 and serum ASCA is an indicator of Crohn's disease within the setting of differentiating Crohn's disease from ulcerative colitis and IBS. This diagnostic method offers a simple to perform assay that may be used with either fecal or serum specimens.

AI/ML Overview

Here's a breakdown of the ASCA-CHEK device's acceptance criteria and the study that supports it, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages) that the device had to meet to be approved. Instead, it presents the performance data and then asserts that, based on these findings, the device is substantially equivalent. Therefore, the "acceptance criteria" inferred here are based on the reported "substantial equivalence" claim relative to the predicate devices.

Metric (vs. Disease)	Target (Inferred from Predicate Performance or Substantial Equivalence Claim)	ASCA-CHEK Performance (All Patients + Controls)	ASCA-CHEK Performance (Adult Patients + Controls)	ASCA-CHEK Performance (Pediatric Patients + Controls)
Sensitivity	Similar to QUANTA Lite™ ASCA (64% in All; 75% in Adults; 58% in Peds)	62%	65%	60%
Specificity	Similar to QUANTA Lite™ ASCA (95% in All; 96% in Adults; 95% in Peds)	93%	95%	86%
Agreement (Overall)	Similar to QUANTA Lite™ ASCA (79% in All; 88% in Adults; 70% in Peds)	78%	84%	68%
Metric (vs. QUANTA Lite™ ASCA)	Target (Inferred Acceptance Level for Equivalence)	ASCA-CHEK Performance (All Patients + Controls)	ASCA-CHEK Performance (Adult Patients + Controls)	ASCA-CHEK Performance (Pediatric Patients + Controls)
Positive Agreement	High (to show agreement with predicate)	80%*	78%*	82%*
Negative Agreement	High (to show agreement with predicate)	88%*	94%*	80%*
Overall Agreement	High (to show agreement with predicate)	85%*	89%*	81%*

*Note: The document references "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic" for these agreement percentages, suggesting these values were deemed acceptable for demonstrating equivalence.

2. Sample Size and Data Provenance

Sample Sizes Used for the Test Set:
- All Patients plus Controls: N = 351 (for ASCA-CHEK vs Disease)
- Adult Patients plus Controls: N = 215 (for ASCA-CHEK vs Disease)
- Pediatric Patients plus Controls: N = 136 (for ASCA-CHEK vs Disease)
- Comparison to QUANTA Lite™ ASCA (overlapping groups): N = 274 (All), N = 138 (Adult), N = 136 (Pediatric)
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "Site: Pediatric Patients plus Controls" and "Site: Adult Patients plus Controls," implying data collection from specific clinical locations, but further details are not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications for establishing the ground truth (diagnosis of Crohn's disease or control status). The "Disease" categorization likely stems from standard clinical diagnostic criteria and specialist evaluation, but the specifics are not detailed.

4. Adjudication Method

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic (ELISA), not an imaging or interpretation-based diagnostic that would typically involve multiple human readers. The study compares the performance of the new device (ASCA-CHEK) against the known disease state and against predicate ELISA devices.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "ASCA-CHEK vs Disease" rows in the performance table represent the standalone performance of the algorithm (the ASCA-CHEK ELISA) in detecting true positive and true negative cases based on a clinical diagnosis of the disease or healthy control status.

7. Type of Ground Truth Used

The ground truth used is "Disease" status, which, in the context of diagnosing Crohn's disease, would typically be established by a combination of clinical findings, endoscopy, imaging, histology (pathology), and other laboratory tests. The document indicates the ASCA-CHEK test result is "an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings," implying that there's a reference standard (the "Disease" column) against which the device's output is compared. It is not explicitly stated if it was expert consensus, pathology alone, or outcomes data, but likely a clinical diagnosis based on established medical criteria.

8. Sample Size for the Training Set

The document does not provide information on the sample size for a training set. This is typical for a 510(k) submission where the primary focus is on demonstrating clinical performance and substantial equivalence of the finished device rather than detailing model development or training data. Being an ELISA, it might not have a "training set" in the sense of a machine learning algorithm.

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

As no training set is described, this information is not provided in the document.

Summary

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K071711

ASCA-CHEK, 510(k)

510(k) SUMMARY OF THE ASCA-CHEK TEST 6.0

Contact Information

	TECHLAB®, Inc.2001 Kraft DriveCorporate Research CenterBlacksburg, VA 24060-6358Phone: 540-953-1664FAX: 540-953-1665Email: cpennington@techlab.com
Date Prepared	July 23, 2007
Product and Trade Name	ASCA-CHEK	NOV 07 2007
Classification	Class II, 21 CFR 866.5785

Predicate Devices

QUANTA Lite™ ASCA IgG (K000732). 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). 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.

Intended Use

Device Description

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ulcerative colitis and IBS. This diagnostic method offers a simple to perform assay that may be used with either fecal or serum specimens.

Test	Description	Format	Turn-around time	Limitations
ASCA-CHEK(Fecal and SerumASCA:K071711)	Intended fordetermining thepresence of Igantibodies againstS. cerevisiae(ASCA antibodies)in fecal andserum specimensof adult andpediatric patientsas an aid in thediagnosis ofCrohn's disease.	ELISA(multi-step)	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 IgGantibodies againstS. cerevisiae(ASCA antibodies)in serum of adultpatients	ELISA(multi-step)	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 IgAantibodies againstS. cerevisiae(ASCA antibodies)in serum of adultpatients	ELISA(multi-step)	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

Combined Analysis for Pediatric and Adult Patients plus Healthy Controls

Site: Pediatric Patients plus Controls	N	Sensitivity or Positive Percent Agreement	Specificity or Negative Percent Agreement	Agreement or Overall Percent Agreement
ASCA-CHEK vs Disease	136	60%	86%	68%
QUANTA LiteTM ASCA vs Disease	136	58%	95%	70%
ASCA-CHEK vs QUANTA LiteTM ASCA	136	82%*	80%*	81%*
Site: Adult Patients plus Controls
ASCA-CHEK vs Disease	215	65%	95%	84%
QUANTA LiteTM ASCA vs Disease	138	75%	96%	88%
ASCA-CHEK vs QUANTA LiteTM ASCA	138	78%*	94%*	89%*
Site: All Patients plus Controls
ASCA-CHEK vs Disease	351	62%	93%	78%
QUANTA LiteTM ASCA vs Disease	274	64%	95%	79%
ASCA-CHEK vs QUANTA LiteTM ASCA	274	80%*	88%*	85%*

*Reference guidance document entitled "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic".

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 for use with both fecal and serum specimens as an in vitro diagnostic aid to help identify patients with Crohn's disease in combination with other clinical and laboratory findings when assessing patients with chronic intestinal illnesses.

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

TECHLAB®, Inc. c/o Mr. Charles Pennington Director of Product Development 2001 Kraft Drive Blacksburg, VA 24060-6358

NOV 0 7 2007

Re: K071711

Trade/Device Name: 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 23, 2007 Received: October 25, 2007

Dear Mr. Pennington:

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 (OS) 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

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Page 2 –

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, or questions on the promotion and advertising of your device, 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance 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,

Robert L. Beaufait

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): K071711

ASCA-CHEK Device Name:

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

Maria M Clan

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division Sign-Off

Office of In Vitro Dlagnostic Device Evaluation and Safety 10

510(k) K071711

Regulation Number and Section

§ 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.”