LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO

K134013 · Bio-Rad Laboratories · JJY · Apr 24, 2014 · Clinical Chemistry

Device Facts

• Record ID: K134013
• Device Name: LYPHOCHEK ALLERGEN SIGE CONTROL, NEGATIVE, LYPOCHEK ALLERGEN SIGE CONTROL, NEGATIVE MINIPAK, LYPHOCHEK ALLERGEN SIGE CO
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Lyphochek Allergen sIgE Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Lyphochek Allergen sIgE Control is a human serum-based, lyophilized quality control material; contains added chemicals, stabilizers, and preservatives. Used in clinical laboratories to monitor precision of allergen-specific IgE testing procedures. Device is reconstituted and processed alongside patient samples using manufacturer-supported reagents and instrumentation. Laboratory personnel compare observed results against provided mean values and ±3SD ranges to verify assay performance; helps ensure accuracy and reliability of clinical testing. Benefits include standardized quality monitoring for allergen testing, reducing risk of erroneous clinical results.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including real-time and accelerated stability studies to establish shelf life (37 months at 2-8°C) and open-vial stability (28 days at 2-8°C). Value assignment was performed via replicate analyses using manufacturer-supported reagents.

Technological Characteristics

Lyophilized human serum-based control material. Two levels: Negative and Panel A. Reconstituted for use. Storage at 2-8°C. Compatible with Siemens IMMULITE 2000/2000 XPi, Phadia ImmunoCAP Series, and Hycor HYTEC 288 analyzers.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific allergen IgE analytes. No specific patient population, age, or gender is targeted as this is an in vitro diagnostic control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Ventrex Laboratories (k832218)

Submission Summary (Full Text)

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510(k) Summary

## Lyphochek Allergen sigE Control

#### 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] Fax: [phone]

## Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

## Date of Summary Preparation

Dec 27th, 2013

#### 2.0 Device Identification

Product Trade Name: Lyphochek Allergen sigE Control l Lyphochek Allergen slgE Control, Negative . Lyphochek Allergen sigE Control, Panel A Common Name: Multi-Analyte Controls, All Kinds (Assayed) Classifications: Class I, Reserved Product Code: JJY Regulation Number: 21 CFR 862.1660

### 3.0 Device to Which Substantial Equivalence is Claimed

Baseline Allergen Controls - Inhalants Controls Ventrex Laboratories Predicate 510(k) Number: K832218

#### 4.0 Description of Device

Lyphochek Allergen slgE Control is prepared from human serum source material with added chemicals, stabilizers, and preservatives.

Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

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#### 5.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed in this insert were derived from replicate analyses and are specific for this lot of product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.

#### 6.0 Intended Use

Lyphochek Allergen sIgE Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

#### 7.0 Comparison of the new device with the Predicate Device

Lyphochek Allergen slgE Control claims substantial equivalence to Baseline Allergen Controls - Inhalants Controls (K832218). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

| Characteristics | Lyphochek Allergen sIgE Control<br>(New Device) | Baseline Allergen Controls - Inhalants<br>Controls (Predicate Device, K832218) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek Allergy Control is intended for use<br>as an assayed quality control serum to monitor<br>the precision of laboratory testing procedures<br>for the analytes listed in this package insert. | Baseline Allergen Controls are human serum<br>based system for use in evaluating the accuracy<br>and precision of allergen specific IgE testing<br>procedures, using either the radioallergosorbent<br>or the enzyme immunoassay method. |
| Matrix | Human Serum | Human Serum |
| Preservatives | Contains preservatives | Contains preservatives |
| Storage unopened<br>(Shelf life) | 2-8°C until expiration date | 2-8°C until expiration date |
| Levels | Lyphochek Allergen sIgE Control, Negative<br>Lyphochek Allergen sIgE Control, Panel A | Baseline Allergen Control-Negative<br>Baseline Allergen Control-Inhalants |
| Differences | | |
| Form | Lyophilized | Liquid |
| Open vial Stability | 28 days at 2 to 8°C | No claims made |
| Fill Volume | 2 mL | 1 mL |
| Allergens | Contains:<br>D1: House dust mite ( <i>Dermatophagoides pteronyssinus</i> ) D2: House dust mite ( <i>Dermatophagoides farinae</i> ) E1: Cat dander ( <i>Felis domesticus</i> ) E3: Horse dander ( <i>Equus caballus</i> ) E5: Dog dander F13: Peanut ( <i>Arachis hypogaea</i> ) G2: Bermuda grass ( <i>Cynodon dactylon</i> ) G3: Orchard Grass ( <i>Dactylis glomerata</i> ) G6: Timothy grass ( <i>Phleum pratense</i> ) M3: Mold ( <i>Aspergillus fumigatus</i> ) M6: Mold ( <i>Alternaria Tenuis</i> ) | Contains:<br>G1: Sweet Vernal Grass G2: Bermuda grass G3: Orchard Grass G4: Meadow Fescue G5: Perennial Rye Grass G6: Timothy Grass G7: Common Reed G8: Kentucky Blue Grass G9: Red Top (Bent Grass) G10: Johnson Grass W16: True (Rough) Marsh Elder W17: Kochia (Firebrush) W22: Careless Weed W23: Yellow Dock T1: Maple (Box Elder) T2: Alder T3: Birch |

## Table 1. Similarities and Differences between new and predicate device ..

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Bio-Rad Laboratories 510 (k) Summary Lyphochek Allergen slgE Control

| Lypnochek Allergen sIgE Control | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | F1: Egg white ( <i>Gallus spp.</i> ) F2: Cow's milk ( <i>Bos. spp.</i> ) | T3: Birch ( <i>Betula</i> ) W6: Mugwort ( <i>Artemisia vulgaris</i> ) | G11: Brown Grass G12: Cultivated Rye G13: Velvet Grass G14: Cultivated Oat Pollen | T5: Beech T6: Mountain Cedar T7: Oak T8: Elm |
| | Does not Contain:<br>G1: Sweet Vernal Grass G4: Meadow Fescue G5: Perennial Rye Grass G7: Common Reed G8: Kentucky Blue Grass G9: Red Top ( <i>Bent Grass</i> ) G10: Johnson Grass G11: Brown Grass G12: Cultivated Rye G13: Velvet Grass G14: Cultivated Oat Pollen G15: Cultivated Wheat Pollen G16: Meadow Foxtail G17: Bahia Grass W1: Common Ragweed W2: Western Ragweed W3: Giant Ragweed W4: False Ragweed W5: Wormwood W7: Oxeye Daisy | W8: Dandelion W9: English Plantain W10: Lamb's Quarter W11: Russian Thistle W12: Goldenrod W16: True (Rough) Marsh Elder W17: Kochia (Firebrush) W22: Careless Weed W23: Yellow Dock T1: Maple (Box Elder) T2: Alder T4: Hazelnut T5: Beech T6: Mountain Cedar T7: Oak T8: Elm T9: Olive Tree T11: Sycamore T12: Willow T14: Cottonwood T16: White Pine T20: Mesquite T21: Pecan Tree E2: Dog Epithelium E4: Cow Dander H1: House dust (Greer) H2: House dust (Hollister-Stier) I6: Cockroach | G11: Brown Grass G12: Cultivated Rye G13: Velvet Grass G14: Cultivated Oat Pollen G15: Cultivated Wheat Pollen G16: Meadow Foxtail G17: Bahia Grass W1: Common Ragweed W2: Western Ragweed W3: Giant Ragweed W4: False Ragweed W5: Wormwood W6: Mugwort (common) W7: Oxeye Daisy W8: Dandelion W9: English Plantain W10: Lamb's Quarter W11: Russian Thistle W12: Goldenrod | T5: Beech T6: Mountain Cedar T7: Oak T8: Elm T9: Olive Tree T11: Sycamore T12: Willow T14: Cottonwood T16: White Pine T20: Mesquite T21: Pecan Tree E1: Cat Epithelium E2: Dog Epithelium E3: Horse Dander E4: Cow Dander H1: House dust (Greer) H2: House dust (Hollister-Stier) D2: Dermatophagoides farinae I6: Cockroach |
| | Does not Contain:<br>D1: House dust mite E5: Dog dander F1: Egg white F2: Cow's milk F13:Peanut M3: Mold M6: Mold | | | |

#### 8.0 Statement of Supporting Data

Real time stability studies were performed to establish open vial stability. Accelerated stability studies were performed for establishing the shelf life stability. The stabilities for Lyphochek Allergen sIgE Control are as follows

| Open vial Stability: | 28 days at 2 to 8°C |
|-----------------------|--------------------------|
| Shelf Life Stability: | 37 Months at 2°C to 8 °C |

#### 9.0 Conclusion

Based on the performance characteristics indicated above, Lyphochek Allergen slgE Control is substantially equivalent to the predicate device (K832218).

All supporting data is retained on file at Bio-Rad Laboratories.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2014

BIO-RAD LABORATORIES C/O SUZANNE S. PARSONS REGULATORY AFFAIRS MANAGER 9500 JERONIMO ROAD IRVINE CA 92618

Re: K134013

Trade/Device Name: Lyphocheck Allergen sIgE Control Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: 1 Product Code: JJY Dated: January 29, 2014 Received: January 30, 2014

Dear Ms. Parsons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Parsons

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Elizabeth A. Stafford -S

for Maria M. Chan. Ph.D.

Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known) K134013

Device Name

Lyphochek Allergen sIgE Control, Negative/Panel A

## Indications for Use (Describe)

Lyphochek Allergen sigE Control is intended for use as an assayed quality control server in one ision of laboratory testing procedures for the analytes listed in this package insert.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FDA USE ONLY CONLY CONLY :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth A. Stafford -S

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