Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay, and there is no mention of AI, ML, or related concepts in the summary.

Therapeutic

No
This device is an in vitro diagnostic (IVD) test that aids in diagnosis by detecting biomarkers in feces; it does not treat or prevent disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The test result is used as an aid in the diagnosis of Crohn's disease in combination with clinical and other laboratory findings." and "FOR IN VITRO DIAGNOSTIC USE." The "Device Description" also mentions it is "an aid in the diagnosis of Crohn's disease."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a laboratory-based ELISA test kit that involves physical reagents and a chemical reaction to detect antibodies in a fecal specimen. This is a hardware-based in vitro diagnostic device, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE."

Furthermore, the description of the device and its function clearly indicates that it is used to test a biological sample (feces) in vitro (outside of the body) to aid in the diagnosis of a disease (Crohn's disease).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NBT

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric IBD and IBS patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Study Type: Clinical Study
Sample Size: N=353 (including healthy controls) for primary analysis; N=285 (excluding healthy controls) for secondary analysis; N=146 (pediatric sites only, excluding healthy controls); N=82 (paired fecal/serum specimens).
Key Results:
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%.
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%.
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%.
The ASCA-CHEK test was tested at four clinical sites and included a mixed patient population including both pediatric and adult patients. There was no difference observed in clinical performance of the ASCA-CHEK test between pediatric and adult patients.
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.
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%.

Key Metrics

For N=353 (Crohn's disease vs. Non-Crohn's disease including healthy controls):
Sensitivity: 57.0% (95% CI: 48.5 - 65.2%)
Specificity: 90.5% (95% CI: 85.5 - 94.0%)
Predicted Positive Value: 80.2% (95% CI: 70.8 - 87.2%)
Predicted Negative Value: 75.7% (95% CI: 69.9 - 80.9%)
Correlation: 77.1% (95% CI: 72.5 - 81.0%)

For N=285 (Crohn's disease vs. Ulcerative colitis and irritable bowel syndrome):
Sensitivity: 57.0% (95% CI: 48.5 - 65.2%)
Specificity: 86.7% (95% CI: 79.8 - 91.6%)
Predicted Positive Value: 81.0% (95% CI: 71.7 - 87.9%)
Predicted Negative Value: 67.0% (95% CI: 59.7 - 73.7%)
Correlation: 71.9% (95% CI: 65.8 - 77.0%)

For N=146 (pediatric sites, Crohn's disease vs. Ulcerative colitis and irritable bowel syndrome):
Sensitivity: 48.4% (95% CI: 35.9 - 61.2%)
Specificity: 91.5% (95% CI: 82.7 - 96.2%)
Predicted Positive Value: 81.6% (95% CI: 65.1 - 91.7%)
Predicted Negative Value: 69.4% (95% CI: 59.7 - 77.8%)

For N=82 (paired fecal/serum specimens, ASCA-CHEK vs. QUANTA Lite™ ASCA IgG Serum test):
Percent Positive Agreement: 70.0% (95% CI: 53.3 – 82.9%)
Percent Negative Agreement: 88.1% (95% CI: 73.6 – 95.5%)
Overall Percent Agreement: 79.3% (95% CI: 69.6 – 86.1%)

Predicate Device(s)

QUANTA Lite™ ASCA IgG (K000732), QUANTA Lite™ ASCA IgA (K000733), ImmuLisa Anti-Saccharomyces Antibody (ASCA) IgG (K032850), ImmuLisa Anti-Saccharomyces Antibody (ASCA) IgA (K032860)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

0

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

1

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
TECHLAB®
ASCA-CHEK	Intended for
determining the
presence of fecal
antibodies against
S. cerevisiae
(ASCA antibodies)
in adult and
pediatric IBD and
IBS patients as an
aid in the diagnosis
of Crohn's disease.	ELISA	75 minutes	ASCA are found in
about 50 to 60% of
persons with Crohn's
disease. The two-step
ELISA procedure
requires multiple wash
steps. The test does
not identify all persons
with Crohn's disease.
QUANTA Lite™
ASCA
(S. cerevisiae) IgG
ELISA (K000732)	Intended for
determining the
presence of serum
antibodies against
S. cerevisiae
(ASCA antibodies)
in adult IBD
patients	ELISA	90 minutes	ASCA serum
antibodies are found in
about 50 to 60% of
persons with Crohn's
disease. The test does
not identify all persons
with Crohn's disease.
QUANTA Lite™
ASCA
(S. cerevisiae) IgA
ELISA (K000733)	Intended for
determining the
presence of serum
antibodies against
S. cerevisiae
(ASCA antibodies)
in adult IBD
patients	ELISA	90 minutes	ASCA serum
antibodies are found in
about 50 to 60% of
persons with Crohn's
disease. The test does
not identify all persons
with Crohn's disease.
ImmuLisa Anti-
Saccharomyces
Antibody (ASCA)
IgG (K032850)	Intended for
determining the
presence of serum
antibodies against
S. cerevisiae
(ASCA antibodies)
in IBD patients	ELISA	90 minutes	ASCA serum
antibodies are found in
about 50 to 60% of
persons with Crohn's
disease. The test does
not identify all persons
with Crohn's disease.
ImmuLisa Anti-
Saccharomyces
Antibody (ASCA)
IgA (K032860)	Intended for
determining the
presence of serum
antibodies against
S. cerevisiae
(ASCA antibodies)
in IBD patients	ELISA	90 minutes	ASCA serum
antibodies are found in
about 50 to 60% of
persons with Crohn's
disease. The test does
not identify all persons
with Crohn's disease.

Comparative information of equivalent devices

2

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's
disease | 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%

3

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 and
irritable 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. and
Adult:
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)

4

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 Assessments
N = 82 | Total #
of
patients | ASCA-CHEK
Fecal Positive
result | QUANTA™ Lite
Serum Positive
results |
|--------------------------------------------|---------------------------|---------------------------------------|-------------------------------------------|
| 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 Serum
test
Positive | QUANTA Lite™
ASCA IgG
Serum test
Negative | 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%

5

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.

6

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.

7

Page 2 -

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

8

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

K051927