(147 days)
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No
The document describes a quality control material for an immunoassay and does not mention any AI or ML components.
No.
The device is a laboratory control for in vitro diagnostic tests to estimate precision and monitor system performance, not to directly treat or diagnose a patient's condition.
No
This device is described as a "Serum Control" used for quality control in in vitro immunoassay procedures. Its purpose is to monitor system performance and estimate precision for assays that determine Helicobacter pylori IgG antibody. It is not the diagnostic device itself, but rather a control for such devices.
No
The device description clearly states it is a "Ready to use stabilized, Liquid Serum Control," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are to be used with "in vitro immunoassay procedures for the qualitative determination of Helicobacter pylori IgG antibody in human serum assays." This clearly indicates the device is used outside of the body to analyze a biological sample (human serum).
- Device Description: The device is described as a "Ready to use stabilized, Liquid Serum Control for qualitative determination of Helicobacter pylori IgG antibody in human serum assays." This further reinforces its use in laboratory testing of a biological sample.
- Purpose: The controls are designed for "routine use to provide a means of estimating precision and monitoring system performance" in these in vitro assays. This is a standard function of IVD quality control materials.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. This device fits this definition.
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Intended Use / Indications for Use
KENLOR H. pylori Serum Control is designed to provide unassayed precision control reagents. The controls are to be used with the in vitro immunoassay procedures for the qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls are designed for routine use to provide a means of estimating precision and monitoring system performance. The controls are not intended to replace reagent controls furnished with the commercial kits. The control should be used like a patient sample to assist in the assessment of the listed analytical procedures.
The usefulness of Quality Control materials for monitoring the accuracy and precision of clinical testing is well documented.
Product codes
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Device Description
Ready to use stabilized, Liquid Serum Control for qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls contain 0.05% Sodium azide as preservative. The human source material is from human Serum and protein fractions of human serum.
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)
Stability of H. pylori antibody in Serum Control were studied by measuring it at a regular interval of time. The control were kept at 2° - 8° C for the shelf life study. The mean of the assigned value is derived from assay of 24 vials that are representative of the lot. Suggested target ranges for quantitative values represent 2 X Standard Deviation (S.D.) of the assayed values. The experimental values are the mean of three vials analyzed at the time period. Studies on closed vial stability conducted over a period of one year at 2° - 8° C indicates that the antibody remains within the assigned range for the duration and condition of the study. An accelerated shelf life stability study was conducted at 37 C for two months. Based on these studies a stability of two years is assigned for closed vials at refrigerated temperatures (2° - 8° C). Opened vials when used as directed and stored at 2º- 8º C are stable up to two months (sixty days).
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
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§ 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).
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510(K) SUMMARY
MAR - 3 1997
Date Prepared : 12/12/96
Submittal's Name : Kenlor Industries, Inc.
Address: 1560 E. Edinger Ave., Suite A-1, Santa Ana, CA 92705, USA
Tel. No. : 714-647-0770
Fax No. : 714-647-0593
Contact Person : Dr. Kamales Som
Classification Name : Serum Control
Common Name : Serum Control
Proprietary Name : Kenlor Liquid H. pylori IgG antibody Serum Control (Unassayed )
Legally marketed Device to which equivalence is claimed : Commercial Serum Controls for H. pylori Antibody marketed with H. pylori antibody test kit by BioAmerica and Elias corporation.
Description of the Device : Ready to use stabilized, Liquid Serum Control for qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls contain 0.05% Sodium azide as preservative. The human source material is from human Serum and protein fractions of human serum.
Intended Use : KENLOR H. pylori Serum Control is designed to provide unassayed precision control reagents. The controls are to be used with the in vitro immunoassay procedures for the qualitative determination of Helicobacter pylori IgG antibody in human serum assays. The controls are designed for routine use to provide a means of estimating precision and monitoring system performance. The controls are not intended to replace reagent controls furnished with the commercial kits. The control should be used like a patient sample to assist in the assessment of the listed analytical procedures.
The usefulness of Quality Control materials for monitoring the accuracy and precision of clinical testing is well documented.
1
SUMMARY OF DATA: Stability of H. pylori antibody in Serum Control were studied by measuring it at a regular interval of time. The control were kept at 2° - 8° C for the shelf life study. The mean of the assigned value is derived from assay of 24 vials that are representative of the lot. Suggested target ranges for quantitative values represent 2 X Standard Deviation (S.D.) of the assayed values. The experimental values are the mean of three vials analyzed at the time period. Studies on closed vial stability conducted over a period of one year at 2° - 8° C indicates that the antibody remains within the assigned range for the duration and condition of the study. An accelerated shelf life stability study was conducted at 37 C for two months. Based on these studies a stability of two years is assigned for closed vials at refrigerated temperatures (2° - 8° C). Opened vials when used as directed and stored at 2º- 8º C are stable up to two months (sixty days).
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