Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay with defined cut-off values for interpretation, and there is no mention of AI or ML in the provided text.

Therapeutic

No
The device is an in vitro diagnostic test for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) to aid in the diagnosis of Crohn's disease, not for treatment.

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. FOR IN VITRO DIAGNOSTIC USE." The "Device Description" also refers to it as a "diagnostic method."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a laboratory-based ELISA test that involves physical reagents, specimen handling (feces and serum), and optical density measurements, indicating it is a hardware-based in vitro diagnostic device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "FOR IN VITRO DIAGNOSTIC USE."
Nature of the Test: The device is an ELISA designed to detect specific antibodies (ASCA) in biological samples (feces and serum) to aid in the diagnosis of a disease (Crohn's disease). This is a hallmark of in vitro diagnostics, which are used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
Intended User/Care Setting: The "Intended User / Care Setting" also reiterates "FOR IN VITRO DIAGNOSTIC USE."

Therefore, based on the provided information, the ASCA-CHEK test is definitively an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

NBT

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.

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 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, sample size, AUC, MRMC, standalone performance, key results)

Combined Analysis for Pediatric and Adult Patients plus Healthy Controls:

Site: Pediatric Patients plus Controls

ASCA-CHEK vs Disease: N = 136, Sensitivity or Positive Percent Agreement = 60%, Specificity or Negative Percent Agreement = 86%, Agreement or Overall Percent Agreement = 68%
QUANTA LiteTM ASCA vs Disease: N = 136, Sensitivity or Positive Percent Agreement = 58%, Specificity or Negative Percent Agreement = 95%, Agreement or Overall Percent Agreement = 70%
ASCA-CHEK vs QUANTA LiteTM ASCA: N = 136, Sensitivity or Positive Percent Agreement = 82%, Specificity or Negative Percent Agreement = 80%, Agreement or Overall Percent Agreement = 81%*

Site: Adult Patients plus Controls

ASCA-CHEK vs Disease: N = 215, Sensitivity or Positive Percent Agreement = 65%, Specificity or Negative Percent Agreement = 95%, Agreement or Overall Percent Agreement = 84%
QUANTA LiteTM ASCA vs Disease: N = 138, Sensitivity or Positive Percent Agreement = 75%, Specificity or Negative Percent Agreement = 96%, Agreement or Overall Percent Agreement = 88%
ASCA-CHEK vs QUANTA LiteTM ASCA: N = 138, Sensitivity or Positive Percent Agreement = 78%, Specificity or Negative Percent Agreement = 94%, Agreement or Overall Percent Agreement = 89%*

Site: All Patients plus Controls

ASCA-CHEK vs Disease: N = 351, Sensitivity or Positive Percent Agreement = 62%, Specificity or Negative Percent Agreement = 93%, Agreement or Overall Percent Agreement = 78%
QUANTA LiteTM ASCA vs Disease: N = 274, Sensitivity or Positive Percent Agreement = 64%, Specificity or Negative Percent Agreement = 95%, Agreement or Overall Percent Agreement = 79%
ASCA-CHEK vs QUANTA LiteTM ASCA: N = 274, Sensitivity or Positive Percent Agreement = 80%, Specificity or Negative Percent Agreement = 88%, Agreement or Overall Percent Agreement = 85%*

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity or Positive Percent Agreement, Specificity or Negative Percent Agreement, Agreement or Overall Percent Agreement. (Specific values are listed in the "Summary of Performance Studies" section).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K000732, K000733

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K071711

ASCA-CHEK, 510(k)

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

Contact Information

| | TECHLAB®, Inc.
2001 Kraft Drive
Corporate Research Center
Blacksburg, VA 24060-6358
Phone: 540-953-1664
FAX: 540-953-1665
Email: 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

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

1

:

.

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
ASCA-CHEK
(Fecal and Serum
ASCA:
K071711)	Intended for
determining the
presence of Ig
antibodies against
S. cerevisiae
(ASCA antibodies)
in fecal and
serum specimens
of adult and
pediatric patients
as an aid in the
diagnosis of
Crohn's disease.	ELISA
(multi-step)	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 IgG
antibodies against
S. cerevisiae
(ASCA antibodies)
in serum of adult
patients	ELISA
(multi-step)	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 IgA
antibodies against
S. cerevisiae
(ASCA antibodies)
in serum of adult
patients	ELISA
(multi-step)	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

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.

3

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

4

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

5

INDICATIONS FOR USE 2.

510(k) Number (if known): K071711

ASCA-CHEK Device Name:

Indications For Use:

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.

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