(167 days)
Not Found
No
The summary describes a visually interpreted immunochemical assay, with no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML development.
No
The device is a diagnostic test (detection of H. pylori antibodies), not a therapeutic device. It aids in diagnosis but does not treat or cure.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients."
No
The device description explicitly states it is a "Visually read, single use test cassette," which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum". This involves testing biological samples (whole blood and serum) in vitro (outside the body) to provide information about a patient's health status (diagnosis of H. pylori infection).
- Device Description: While brief, the description of a "single use test cassette" is consistent with the format of many IVD tests.
- Intended User / Care Setting: "Laboratory Test" indicates it's used in a laboratory setting, which is typical for IVD testing.
The core function of analyzing biological samples in vitro to aid in diagnosis is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.
Product codes (comma separated list FDA assigned to the subject device)
LYR
Device Description
Visually read, single use test cassette.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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
510(k) Summary
MAR - 3 1998
K973523
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Submitter Owner/Operator name, address, Cortecs Diagnostics Limited contact Newtech Square Deeside Industrial Park Deeside, Flintshire CH5 2NT Wales
USA Regulatory Representative/Distributor Boehringer Mannheim Corporation 9115 Hague Rd. Indianapolis. IN 46250 (317) 845-2000
Contact Person: Mike Flis
Date Prepared: September 15, 1997
- Device name Proprietary name: AccuStat™ H. pylori One Step Test Common name: Laboratory Test for the Detection of Antibodies to Helicobacter pylori Classification name: Campylobacter fetus serological reagents
The Cortecs Diagnostics Limited AccuStat H. pylori One Step Test is 3) Predicate device substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Cortecs Helisal Rapid Blood Test (510(k) file #K953686). The AccuStat H. pylori One Step Test is also substantially equivalent to Smith Kline FlexSure HP and QuickVue One-Step H. Pylori tests. The latter two tests have been determined by the Center for Disease Control and Prevention (CDC) as being eligible for a CLIA waiver due to the simple methodologies employed.
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510(k) Summary, Continued
ﻤﺴﺴﺴﺴﺴ
| 4) Device Description | Visually read, single use test cassette. |
|---|---|
| 5) Intended use | The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori ( H. pylori ) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients. |
Continued on next page.
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510(k) Summary, Continued
ﺍﻟﻤﺴﺘﻘﻠﺔ
| Feature | AccuStat H. pylori
One Step Test
(new device) | Cortecs Helisal Rapid
Blood Test
(Primary Predicate) | Smith Kline FlexSure
HP Test
(Secondary Predicate) | Quidel QuickVue
One-Step H. pylori
Test
(Secondary Predicate) |
|---------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Detects | Human antibody to
Helicobacter pylori | Human IgG antibody to
Helicobacter pylori | Human IgG antibody to
Helicobacter pylori | Human IgG antibody to
Helicobacter pylori |
| Methodology | Immunochromatography
(visually interpreted) | Immunochromatography
(visually interpreted) | Immunochromatography
(visually interpreted) | Immunochromatography
(visually interpreted) |
| Qualitative Test? | Yes | Yes | Yes | Yes |
| Test Components | Single use test cassette | Single use test card and
buffer | Single use test card and
buffer | Single use test cassette |
| Minimum test
sample | 1-2 drops of whole blood or
serum (50 µL) | 20µL whole blood | 80µL whole blood or serum | 140 µL whole blood or serum |
| Procedural Steps | 1. Add sample
2. Wait
3. Read result | 1. Fill capillary tube
2. Drop tube in buffer
3. Mix
4. Add sample to test card
5. Wait
6. Wipe card
7. Add reagent
8. Wait
9. Read result | 1. Add buffer
2. Add sample
3. Wait
4. Close test card
5. Wait
6. Read result | 1. Add sample
2. Wait
3. Read result |
| Total test time | ≤ 5 minutes | 5-10 minutes | 6-7 minutes | 10 minutes |
| Quality control | Internal procedural control | Internal procedural control | Internal procedural control | Internal procedural control |
| Storage
Recommendation | Room temperature | Room temperature | Refrigerated | Room temperature |
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હુદ્દી 0
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3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Consultant Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, IN 46250
MAR - 3 1998
Re: K973523 Trade Name: AccuStat H. pylori One Step Test Regulatory Class: I Product Code: LYR Dated: December 15, 1997 Received: December 16, 1997
Dear Mr. Flis:
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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System -Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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.
4
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
5
Indications for Use Statement
510(k) Number (if known): 1 973523 Device Name: AccuStat H. pylori One Step Test
Indications for Use:
The AccuStat™ H. pylori One Step test is a qualitative immunochemical membrane assay for the detection of antibodies to Helicobacter pylori (H. pylori) in whole blood and serum by visual interpretation. The test is for use as an aid in the diagnosis of H. pylori infection in symptomatic patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
Prescription Use V (Per 21 CFR 801.109)
510(k) Number
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Öst