(135 days)
Not Found
HM-CAP Helicobacter pylori Enzyme Immunoassay
No
The device is described as a rapid, visually read, qualitative immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML algorithms. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is a diagnostic immunoassay used to detect antibodies for H. pylori, aiding in the diagnosis of infection, rather than providing therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "an aid in the diagnosis of H. pylori infection."
No
The device is a rapid, visually read, qualitative immunoassay, which is a physical test kit involving reagents and a test strip, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of human IgG antibodies specific to Helicobacter pylori in serum, plasma, and whole blood specimens." This involves testing biological samples in vitro (outside the body).
- Device Description: The description reinforces that it's a "qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in human serum, plasma, or whole blood." Again, this describes a test performed on biological samples.
- Performance Studies: The performance studies involve testing "serum specimens" and comparing the results to other diagnostic methods (biopsy and another immunoassay), which is characteristic of IVD device validation.
The core function of the device is to analyze biological samples to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Abbott TestPack Plus H. pylori is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in human serum, plasma, or whole blood. The assay is intended for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. There are two kit configurations associated with the Abbott TestPack Plus H. pylori assay, one where the intended use is for testing serum, plasma, venous whole blood, and fingerstick whole blood specimens and a second where the intended use is for testing whole blood specimens collected by fingerstick or venipuncture.
The Abbott TestPack®Plus™ H. pylori assay is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in serum, plasma, and whole blood specimens from symptomatic adults.
Product codes
LYR
Device Description
Abbott TestPack Plus H. pylori is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in human serum, plasma, or whole blood.
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
symptomatic adults.
Intended User / Care Setting
health professionals
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
Fresh serum specimens were obtained from 107 symptomatic patients undergoing endoscopic examination at two clinical sites. Forty nine (49) specimens were tested at one site, of which four were excluded from the analysis because the biopsy test results were indeterminate for H. pylori infection. Fifty eight (58) specimens were tested and analyzed at the second site.
A comparison was made with the TestPack assay to biopsy and the HM-CAP assay using 135 previously characterized serum specimens.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1 (Clinical Sites)
- Sample Size: 107 fresh serum specimens (45 from site 1, 58 from site 2) from symptomatic patients undergoing endoscopic examination.
- Key Results:
- Site 1: Sensitivity 90.9% (10/11) (95% C.I. 58.7% to 99.8%), Specificity 76.5% (26/34) (95% C.I. 58.8% to 89.3%). All 8 TestPack positive and biopsy negative specimens were positive by HM-CAP.
- Site 2: Sensitivity 70.8% (17/24) (95% C.I. 48.9% to 87.4%), Specificity 88.2% (30/34) (95% C.I. 72.6% to 96.7%). All 4 TestPack positive and biopsy negative specimens were positive by HM-CAP. Two of seven TestPack negative and biopsy positive specimens were negative by HM-CAP.
Study 2 (Comparison with Biopsy)
- Sample Size: 135 previously characterized serum specimens.
- Key Results:
- Agreement: 92.0% (124/135)
- Sensitivity: 92.3% (96/104) (85.4% to 96.6%)
- Specificity: 90.3% (28/31) (74.3% to 98.0%)
Study 3 (Comparison with HM-CAP)
- Sample Size: 133 previously characterized serum specimens (2 of 135 specimens were HM-CAP indeterminate and excluded).
- Key Results:
- Relative Agreement: 94.0% (125/133)
- Relative Sensitivity: 95.0% (96/101) (88.8% to 98.4%)
- Relative Specificity: 90.6% (29/32) (75.0% to 98.0%)
Overall Conclusion: The data demonstrate that the Abbott TestPack Plus H. pylori assay is as safe and effective as, and is substantially equivalent to, the HM-CAP Helicobacter pylori Enzyme Immunoassay.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Sensitivity (Site 1): 90.9% (10/11) (95% C.I. of 58.7% to 99.8%)
- Specificity (Site 1): 76.5% (26/34) (95% C.I. of 58.8% to 89.3%)
- Sensitivity (Site 2): 70.8% (17/24) (95% C.I. of 48.9% to 87.4%)
- Specificity (Site 2): 88.2% (30/34) (95% C.I. of 72.6% to 96.7%)
- Agreement (Compared to Biopsy): 92.0% (124/135)
- Sensitivity (Compared to Biopsy): 92.3% (96/104) (85.4% to 96.6%)
- Specificity (Compared to Biopsy): 90.3% (28/31) (74.3% to 98.0%)
- Relative Agreement (Compared to HM-CAP): 94.0% (125/133)
- Relative Sensitivity (Compared to HM-CAP): 95.0% (96/101) (88.8% to 98.4%)
- Relative Specificity (Compared to HM-CAP): 90.6% (29/32) (75.0% to 98.0%)
Predicate Device(s)
Not Found
Reference Device(s)
HM-CAP Helicobacter pylori Enzyme Immunoassay
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).
0
KC982362
NOV 1 8 1998
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Section II
510(k) Summary
.
Abbott TestPack Plus H. pylori 510(k) July 1998 Hpsecii.lwp
Volume I Section II
1
510(k) Summary Abbott TestPack® Plus™ H. pylori
Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information as presented in the Premarket Notification [510(k)] for the Abbott TestPack Plus H. pylori assay constitutes data supporting a substantially equivalent determination.
Abbott TestPack Plus H. pylori is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in human serum, plasma, or whole blood. The assay is intended for use by health professionals as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. There are two kit configurations associated with the Abbott TestPack Plus H. pylori assay, one where the intended use is for testing serum, plasma, venous whole blood, and fingerstick whole blood specimens and a second where the intended use is for testing whole blood specimens collected by fingerstick or venipuncture.
Substantial equivalence has been demonstrated between the Abbott TestPack Plus H. pylori assay and the HM-CAPm Helicobacter pylori Enzyme Immunoassay for the detection of H. pylori specific IgG antibodies. The intended use of the HM-CAP assay is for the qualitative detection of IgG antibody to H. pylori in human serum and it is used as an adjunct in the diagnosis of infection by H. pylori.
Fresh serum specimens were obtained from 107 symptomatic patients undergoing endoscopic examination at two clinical sites. Forty nine (49) specimens were tested at one site, of which four were excluded from the analysis because the biopsy test results were indeterminate for H. pylori infection. The sensitivity and specificity were 90.9% (10/11) (95% C.I. of 58.7% to 99.8%) and 76.5% (26/34) (95% C.I. of 58.8% to 89.3%), respectively. The presence of H. pylori specific IgG antibodies in all eight TestPack
2
positive and biopsy negative specimens from this site were detected by the HM-CAP assay. Fifty eight (58) specimens were tested and analyzed at the second site resulting in a sensitivity and specificity of 70.8% (17/24) (95% C.I. of 48.9% to 87.4%) and 88.2% (30/34) (95% C.I. of 72.6% to 96.7%), respectively. The presence of H. pylori specific IgG antibodies in all four TestPack positive and biopsy negative specimens from this second site was detected by the HM-CAP assay. Similarly, the absence of H. pylori specific IgG antibodies in two of seven TestPack negative and biopsy positive specimens was observed by the HM-CAP assay.
A comparison was made with the TestPack assay to biopsy and the HM-CAP assay using 135 previously characterized serum specimens. (Refer to Table 1.) Two of the 135 specimens were HM-CAP indeterminate and not used in the TestPack to HM-CAP analysis. (Refer to Table 2.)
| Table 1 |
|---|
| Abbott TestPack Plus H. pylori |
| Compared to Biopsy |
| n | Agreement | Sensitivity
(95% C.I.) | Specificity
(95% C.I.) |
|-----|-----------------|------------------------------------|-----------------------------------|
| 135 | 92.0% (124/135) | 92.3% (96/104)
(85.4% to 96.6%) | 90.3% (28/31)
(74.3% to 98.0%) |
Table 2 Abbott TestPack Plus H. pylori Compared to HM-CAP
| n | Relative
Agreement | Relative Sensitivity
(95% C.I.) | Relative Specificity
(95% C.I.) |
|-----|-----------------------|------------------------------------|------------------------------------|
| 133 | 94.0% (125/133) | 95.0% (96/101)
(88.8% to 98.4%) | 90.6% (29/32)
(75.0% to 98.0%) |
Abbott TestPack Plus H. pylori 510(k) July 1998 Hpsecii lwp
3
In conclusion, these data demonstrate that the Abbott TestPack Plus H. pylori assay is as safe and effective as, and is substantially equivalent to, the HM-CAP Helicobacter pylori Enzyme Immunoassay.
Prepared and Submitted July 2, 1998 by: Abbott Laboratories Irene Powers ← Regulatory Section Leader ADD Regulatory Affairs 1-847-937-1998 200 Abbott Park Road Abbott Park, IL 60064-3537
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Irene Powers Section Leader - Devices ADD Regulatory Affairs Dept. 9V6, Building AP31 200 Abbott Park Road Abbott Park, Illinois 60060-3537
Re : K982362/S1 Abbott TestPack® Plus™ H.pylori Trade Name: Requlatory Class: I Product Code: LYR Dated: September 24, 1998 Received: September 25, 1998
Dear Ms. Powers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K982362
Device Name: Abbott TestPack® Plus™ H. pylori
Indications For Use:
The Abbott TestPack®Plus™ H. pylori assay is a rapid, visually read, qualitative immunoassay for the detection of human IgG antibodies specific to Helicobacter pylori in serum, plasma, and whole blood specimens from symptomatic adults.
Reference:
1
-
- McGuigan JE. Peptic Ulcer and Gastritis. In: Harrison's Priniciples of Internal Medicine, 12th Edition, New York: McGraw-Hill, 1991:1229-1248.
Woody Dubres
- McGuigan JE. Peptic Ulcer and Gastritis. In: Harrison's Priniciples of Internal Medicine, 12th Edition, New York: McGraw-Hill, 1991:1229-1248.
510/k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use - - -
(Optional Format 1-2-96)