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

Indications for 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) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k134013

B. Purpose for Submission:
New device

C. Measurand:
Immunoglobulin E specific (sIgE) for allergen components from House Dust Mite (Dermatophagoides pteronyssinus), Cat dander (Felis domesticus), Horse dander (Equus caballus), Dog dander (Canis familiaris), Egg white (Gallus spp.), Cow’s milk (Bos spp.), Peanut (Arachis hypogaea), Bermuda grass (Cynodon dactylon), Orchard Grass (Dactylis glomerata), Timothy grass (Phleum pratense), Mold (Aspergillus fumigatus), Mold (Alternaria tenuis), Birch (Betula), and Mugwort (Artemisia vulgaris)

D. Type of Test:
Not applicable

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
Lyphocheck Allergen sIgE Control Negative
Lyphocheck Allergen sIgE Control Panel A

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660 Quality Control Material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJY – Multi-analyte controls, all kinds (assayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
Lyphocheck 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.

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2. Indication(s) for use:
Same as intended use

3. Special conditions for use statement(s):
For in vitro diagnostic use

4. Special instrument requirements:
Values are listed in the labeling for several analyzers. Values were assigned on these analyzers: Siemens IMMULITE 2000/2000 XPi, Phadia ImmunoCAP Series, Hycor HYTEC 288.

I. Device Description:
Lyphocheck Allergen sIgE Controls are packaged as lyophilized vials of Allergen sIgE Control Negative and Allergen sIgE Control Panel A. Control Panel A contains IgE antibodies specific for the listed analytes. The Negative and Panel A controls are either packaged as six vials, two mL per vial, or as a MiniPak of a two mL vial.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Ventrex Laboratories

2. Predicate 510(k) number(s):
k832218

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Human serum | Human serum |
| Levels | Two levels | Two levels |
| Shelf life storage | 2-8°C until expiration date | 2-8°C until expiration date |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Lyphocheck Allergy 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. | Baseline Allergen Controls are human serum based system for use in evaluating accuracy and precision of allergen specific IgE testing procedures, using either the radioallergosorbent or the enzyme immunoassay method. |
| Form | Lyophilized | Liquid |
| Open vial stability | 28 days at 2-8°C | No claims made |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Fill volume | 2 mL | 1 mL |
| Two Control Level contents | Lyphocheck Allergen sIgE Control, Negative
Lyphocheck Allergen sIgE Control, Panel A (Inhalants and Food | Baseline Allergen Control
– Negative
Baseline Allergen Control
– Inhalants |
| Allergens Contained in Device: | D1: House dust mite (Dermatophagoides pteronyssinus)
D2: House dust mite (Dermatophagoides farinae)
E1: Cat dander (Felis domesticus)
E3: Horse dander (Equus caballus)
E5: Dog dander (Canis familiaris)
F1: Egg white (Gallus spp.)
F2: Cow’s milk (Bos. spp.)
F13: Peanut (Arachis hypogaea)
G2: Bermuda grass (Cynodon dactylon)
G3: Orchard Grass (Dactylis glomerata)
G6: Timothy grass (Phleum pratense)
M3: Mold (Aspergillus fumigatus)
M6: Mold (Alternaria tenuis)
T3: Birch (Betula)
W6: Mugwort (Artemisia vulgaris) | E1: Cat Epithelium
E2: Dog Epithelium
E3: Horse Dander
E4: Cow Dander
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
G11: Brown Grass
G12: Cultivated Rye
G13: Velvet Grass
G14: Cultivated Oat Pollen
G15: Cultivated Wheat Pollen
G16: Meadow Foxtail
G17: Bahia Grass
H1: House dust (Greer)
H2: House dust (Hollister-Stier) Dermatophagoides farinae
I6: Cockroach
T1: Maple (Box Elder)
T2: Alder
T3: Birch
T4: Hazelnut
T5: Beech
T6: Mountain Cedar
T7: Oak
T8: Elm |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | T9: Olive Tree
T11: Sycamore
T12: Willow
T14: Cottonwood
T16: White Pine
T20: Mesquite
T21: Pecan Tree
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
W16: True (Rough) Marsh Elder
W17: Kochia (Firebrush)
W22: Careless Weed
W23: Yellow Dock |

K. Standard/Guidance Document Referenced (if applicable):
None

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Value assignment: The mean values and the corresponding $\pm 3\mathrm{SD}$ ranges printed in this insert were derived from replicate analyses and are specific for this lot of

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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. The sponsor recommends that each laboratory establish its own acceptable ranges and the values provided be used only as guides.

**Stability:** The sponsor’s unopened, lyophilized shelf-life and reconstituted open-vial stability protocols and acceptance criteria were reviewed and found to be acceptable.

**Shelf-life stability studies:** Accelerated stability studies: control materials were stored at three different elevated temperatures then periodically reconstituted and tested against vials stored under normal conditions (2-8°C). Accelerated stability study model and data supports shelf life claim of 37 months at 2-8°C storage. Real time testing is ongoing.

Open-vial stability studies: the reconstituted controls were tested at periodic intervals at day 0, 3, 28 and 35. The results support the claim of 28 days open vial stability when stored at 2-8°C.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:

a. Method comparison with predicate device:
Not applicable

b. Matrix comparison:
Not applicable

3. Clinical studies:

a. Clinical Sensitivity:
Not applicable

b. Clinical specificity:
Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

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5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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