KENLOR H. PYLORI CONTROL SERUM

K964014 · Kenlor Industries, Inc. · LYR · Mar 3, 1997 · Microbiology

Device Facts

• Record ID: K964014
• Device Name: KENLOR H. PYLORI CONTROL SERUM
• Applicant: Kenlor Industries, Inc.
• Product Code: LYR · Microbiology
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

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.

Device Story

Liquid, ready-to-use, stabilized serum control containing human serum and protein fractions; preserved with 0.05% sodium azide. Used in clinical laboratories to monitor performance of H. pylori IgG antibody immunoassay test kits. Operates as a surrogate patient sample; processed alongside clinical specimens to assess analytical precision and accuracy. Provides healthcare providers with a means to verify system stability and assay reliability. Benefits patient care by ensuring consistent, accurate diagnostic results for H. pylori infection.

Clinical Evidence

Bench testing only. Stability studies conducted on 24 vials per lot. Closed vial stability validated for one year at 2-8°C; accelerated shelf-life study at 37°C for two months supports a two-year shelf life. Opened vial stability validated for 60 days at 2-8°C. Assigned values derived from mean assay results; target ranges established at 2x Standard Deviation.

Technological Characteristics

Stabilized liquid serum control; human serum and protein fractions; 0.05% sodium azide preservative. Form factor: liquid in vials. Storage: 2-8°C. No electronic, software, or energy-based components.

Indications for Use

Indicated for use as an unassayed precision control reagent for in vitro immunoassay procedures qualitatively determining Helicobacter pylori IgG antibodies in human serum. Intended for routine laboratory use to monitor system performance and estimate precision.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter 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.

Predicate Devices

• Commercial Serum Controls for H. pylori Antibody (BioAmerica)
• Commercial Serum Controls for H. pylori Antibody (Elias corporation)

Submission Summary (Full Text)

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K964014

# 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.

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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 $2^{\circ} - 8^{\circ}$ 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 $2^{\circ} - 8^{\circ}$ 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 ($2^{\circ} - 8^{\circ}$ C). Opened vials when used as directed and stored at $2^{\circ} - 8^{\circ}$ C are stable up to two months (sixty days).