(76 days)
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No
The summary describes a standard ELISA assay and mentions an automated instrument, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML.
No
The device is described as an "in vitro diagnostic use only" assay for the semi-quantitative determination of specific IgG autoantibodies, used as an aid in diagnosis, not for treating a condition.
Yes
The device is used as an "aid in the diagnosis of diseases" and is explicitly stated as being "for in vitro diagnostic use only."
No
The device description clearly states it is an "Enzyme linked immunosorbent assay method" and is designed for use with an "Automated EIA instrument," indicating it is a physical in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly stated: The "Intended Use / Indications for Use" section clearly states "For in vitro diagnostic use only."
- Method: It uses an "Enzyme linked immunosorbent assay method," which is a common technique for in vitro testing of biological samples.
- Sample type: It analyzes "human serum," which is a biological sample taken from a patient.
- Purpose: The results are used "as an aid in the diagnosis of diseases," specifically Pernicious Anaemia, by detecting autoantibodies in the serum. This is a diagnostic purpose performed outside of the body.
N/A
Intended Use / Indications for Use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum.
Uses:
The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
For in vitro diagnostic use only.
Product codes
MLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 866.5110 Antiparietal antibody immunological test system.
(a)
Identification. An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).(b)
Classification. Class II (performance standards).
0
Image /page/0/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 image of three birds in flight, arranged in a vertical stack. The birds are silhouetted and have a simple, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 4 1999
Ms. Danielle M. Knight Quality Manager Cogent Diagnostics Limited Pentlands Science Park Bush Loan Penicuik Midlothian EH26 0PL Scotland, UK
Re: K991942
Trade Name: Cogent Autostat™ II α-GPC ELISA, Hycor Hy•Tec α-GPC ELISA Regulatory Class: II Product Code: MLE Dated: June 4, 1999 Received: June 9, 1999
Dear Ms. Knight:
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 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.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
2
| Page | of |
|---|---|
| ------ | ---- |
| 510(k) Number (if known): | K991942 |
|---|---|
| --------------------------- | --------- |
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum.
Uses:
The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
For in vitro diagnostic use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter & Mauri
Rich. Ctr. RR
(Division Sign-Off
Division of Clinical Laboratory Devices K991942
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
ーズ
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
3
长991942
Indications for Use - Hy•Tec Kit.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GPC in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.
Uses:
The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.
Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
For in vitro diagnostic use only.
Dieter E. Mapesin
(Division Sign-Off) Division of Clinical Laboratory De 10(k) Number
Prescription Use