K Number

Device Name

IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)

Manufacturer

Siemens Healthcare Diagnostics Inc.

Date Cleared

2013-10-30

(30 days)

Product Code

JJX

Regulation Number

862.1660

Intended Use

The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert. The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

Device Description

The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 2 mL each. L2UNCVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. L2UNCVM2, L2UNCVM3 and L2UNCVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives. The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 3 mL each. LIECVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. LIECVM2, LIECVM3 and LIECVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives.

More Information

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Type

Center

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Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

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Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K102269

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes calibration verification materials for an in vitro diagnostic assay and does not mention any AI or ML components in the device description or performance studies.

Therapeutic

No.
This device is a calibration verification material intended for in vitro diagnostic use to control and verify assays, not to treat or diagnose patients directly.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".

SaMD (Software as a Medical Device)

The device description clearly states it is supplied in liquid form in vials and consists of serum matrix and human IgE positive serum, indicating it is a physical material, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use..." and "The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use...".
Purpose: The device is intended as a control for calibration verification of an in vitro diagnostic assay (IMMULITE 2000 3gAllergy Specific IgE assay and IMMULITE 2000 Total IgE assay). This function is directly related to ensuring the accuracy and reliability of an IVD test.
Intended User/Care Setting: It is indicated for "For in vitro diagnostic use."

The information provided strongly supports the classification of this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.
The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

Product codes (comma separated list FDA assigned to the subject device)

JJX

Device Description

The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 2 mL each. L2UNCVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. L2UNCVM2, L2UNCVM3 and L2UNCVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives.
The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 3 mL each. LIECVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. LIECVM2, LIECVM3 and LIECVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Applicable

Description of the test set, sample size, data source, and annotation protocol

Not Applicable

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

IMMULITE 2000 3gAllergy Specific IgE CVM:
Stability Study: The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Allergy Specific IgE Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 systems throughout the established shelf life of the CVM. The IMMULITE® 2000 Allergy Specific IgE Calibration Verification Materials (CVMs) are stable up to 1.5 years when stored at -20℃ prior to opening.
Stability Protocol Summary: The CVM study protocols are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) and the dose value determined from the reference calibrator curve, as summarized in Table 2.
Stability Acceptance Criteria Summary: The Acceptance Criteria for the IMMULITE 3gAllergy Specific IgE Calibration Verification Material (CVM) are in 2 parts. Part 1 consists of the Guideline acceptance criteria which require dose value of stability calibrator/CVM to fall between ±20% of assigned dose for CVM level 2. ±10% for CVM level 3 and ±15% for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±20% of assiened dose for CVM level 2, ±10% for CVM level 3 and ±15% for CVM level 4, then additional data review is conducted using part 2 criteria.
Value Assignment: The IMMULITE internal calibrators and likewise CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using 3gAllergy Specific IgE antigen stock sourced from Scipac and are traceable to WHO 2nd IRP (75/502). The calibrators/CVMs are manufactured using qualified materials and measurement procedures. The calibrators/CVMs were tested on 27 replicates in total comprised of 9 runs, 8 systems and 3 different reagent kit lots. The Calibrators/CVMs dose values were determined using a curve generated by assigned reference calibrators. The calibrator/CVM values are calculated based on the recovered values for each run on each instrument independently. Calibrator/CVM values are then averaged across all systems.

IMMULITE 2000 Total IgE CVM:
Stability Summary: The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Total IgE Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULIT:E 2000 systems throughout the established shelf life of the CVM. The IMMULITE® 2000 Total IgE Calibration Verification Materials (CVMs) are stable for up to 4 years when stored at -20℃ prior to opening, supporting the claim of 3.5 years shelf life.
Stability Protocol Summary: The CVM study protocols are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) and the dose value determined from the reference calibrator curve, as summarized in Table 2.
Stability Acceptance Criteria Summary: The Acceptance Criteria for the IMMULITE Total IgE Calibration Verification Material (CVM) are in 2 parts. Part 1 consists of the Guideline acceptance criteria which require dose value of stability calibrator/CVM to fall between ±20% of assigned dose for CVM level 2, ±10% for CVM level 3 and ±15% for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±20% of assigned dose for CVM level 2, ±10% for CVM level 3 and ±15% for CVM level 4, then additional data review is conducted using part 2 criteria.
Value Assignment: The IMMULITE internal calibrators and likewise CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using Total IgE antigen stock sourced from Bioresource and are traceable to WHO 2nd IRP (75/502). The calibrators/CVMs are manufactured using qualified materials and measurement procedures. The calibrators/CVMs were tested on 27 replicates in total comprised of 9 runs, 8 systems and 5 different reagent kit lots. The Calibrators/CVMs dose values were determined using a curve generated by assigned reference calibrators. The calibrator/CVM values are calculated based on the recovered values for each run on each instrument independently. Calibrator/CVM values are then averaged across all systems.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

IMMULITE 2000 3gAllergy Specific IgE CVM:

CVM 1: Target Mean (kU/L) 0.00, Guideline Range (kU/L) ≤0.10, Precision (% CV) N/A
CVM 2: Target Mean (kU/L) 0.19, SD 0.023, Guideline Range (kU/L) 0.144 - 0.236, Precision (% CV) ≤24
CVM 3: Target Mean (kU/L) 3.31, SD 0.165, Guideline Range (kU/L) 2.98 - 3.64, Precision (% CV) ≤10
CVM 4: Target Mean (kU/L) 107*, Guideline Range (kU/L) -, Precision (% CV) -
80% CVM 4, 20% CVM1*: Target Mean (kU/L) 85.6, SD 6.4, Guideline Range (kU/L) 72.8- 98.4, Precision (% CV) ≤15
Assay Range: 0.10 - 100 kU/L

IMMULITE 2000 Total IgE CVM:

CVM 1: Target Mean (IU/L) 0.00, Guideline Range (IU/L) ≤1.00, Precision (% CV) N/A
CVM 2: Target Mean (IU/L) 2.91, SD 0.3, Guideline Range (IU/L) 2.3 - 3.5, Precision (% CV) ≤20
CVM 3: Target Mean (IU/L) 100, SD 7.0, Guideline Range (IU/L) 86.0 - 114, Precision (% CV) ≤14
CVM 4: Target Mean (IU/L) 2492, Guideline Range (IU/L) -, Precision (% CV) -
85% CVM 4, 15% CVM 1: Target Mean (IU/L) 2065, SD 206.5, Guideline Range (IU/L) 1652 - 2478, Precision (% CV) ≤20
Assay Range: 1 - 2000 IU/L

Predicate Device(s)

K102269

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

IMMULITE 2000 3gAllergy Specific IgE CVM

510(k) Summary as Required by 21 CFR 807.92

A. 510(k) Number: K133122

OCT 3 0 2013

B. Purpose for Submission: New device

C. Measurand: Quality Control materials for IMMULITE 2000 3gAllergy Specific IgE assay

D. Type of Test: Calibration Verification Material for IMMULITE 2000 3gAllergy Specific IgE assay
E. Applicant:

Siemens Healthcare Diagnostics Inc. Mailing Address: 511 Benedict Avenue Tarrytown, NY 10591 Contact Person: Susan Brocchi, RAC Sr. Regulatory Affairs Specialist Phone Number: (914)-524-2525 Fax Number: (914)-524-2101 E-mail Address: susan.brocchi@siemens.com Date Prepared:

September 27, 2013

.

First Proprietary and Established Names:

Trade name: IMMULITE® 2000 3gAllergy Specific IgE Calibration Verification Material (CVM)

Common name: Calibration Verification Material (CVM) Classification name: Single (specified) Analyte Controls (assayed and unassayed)

G. Regulatory Information:

Regulation Section: 21 CFR 862.1660 Classification: Class I (Reserved) Products Code: JJX - Single (specified) Analyte Controls (assayed and unassaved) Panel: Immunology (82)

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

H. Intended Use / Indicartions for Use:

1. Intended / Indications for Use

2. Special Conditions for Use:

For prescription use only. For in vitro diagnostic use. The IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material is not intended to be used as a primary calibrator or control material.

3. Special Instrument Requirements:

IMMULITE® 2000 System

I. Device Description:

J. Substantial Equivalence Information:

Predicate Device name: Elecsys IgE CalCheck 5 Predicate 510(k) number: K102269 Comparison with predicate:

A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 Allergy Specific IgE Calibration Verification Material (CVM) is substantially equivalent to the predicate device, Elecsys IgE CalCheck 5, as summarized in Table 1.

SIMILARITIES
	Candidate Device	Predicate Device
	IMMULITE 2000 Allergy
Specific IgE CVM	Elecsys IgE CalCheck 5
Intended
Use	The IMMULITE
2000 3gAllergy Specific IgE
Calibration Verification Material
(CVM) is intended for in vitro
diagnostic use, as a control for
calibration verification of the
IMMULITE 2000 3gAllergy	For use in calibration verification and
for use in the verification of the assay
range established by the Elecsys IgE II
reagent on the indicated Elecsys and
cobas e immunoassay analyzers.

Table 1: Substantial Equivalence Comparison

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

	SIMILARITIES
	Specific IgE assay on
IMMULITE 2000 systems as
indicated in the CVM Package
Insert.
Analyte	IgE	Same

	DIFFERENCES
	New Device	Predicate Device
	IMMULITE 2000 Allergy
Specific IgE CVM	Elecsys IgE CalCheck 5
Form	Liquid	Lyophilized
Levels	4	5
Matrix	Equine Serum	Human Serum
Storage	Unopened: Store at ≤ -20°C until
the expiration date
Opened: Use immediately after
opening. Discard any unused
material.	Unopened: Store at 2-8°C until the
expiration date
Reconstituted: 15-25°C, 4 hours

K. Standard/Guidance Document Referenced:

· CEN 13640 Stability Testing of In Vitro Diagnostic Reagents
· Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control Material
· Guidance for Industry and FDA Staff Bundling Multiple Devices or Multiple Indications in a Single Submission

L. Test Principle:

Calibration verification is not a requirement of the IMMULITE 2000 system or the IMMULITE 2000 Allergy Specific IgE assay. CVMs are used by laboratories that wish to document calibration verification as required by certification agencies.

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:

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

Traceability:

The IMMULITE 3gAllergy Specific IgE CVMs are traceable to WHO 2nd IRP (75/502). The CVMs are manufactured using qualified materials and measurement procedures.

Stability Summary:

The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Allergy Specific IgE Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 systems throughout the established shelf life of the CVM. The IMMULITE® 2000 Allergy Specific IgE Calibration Verification Materials (CVMs) are stable up to 1.5 years when stored at -20℃ prior to opening.

Stability Protocol Summary:

The CVM study protocols are run as part of the calibrator stability testing. The stability calibrators/CVMs are run in duplicate (as a minimum) and the dose value determined from the reference calibrator curve, as summarized in Table 2.

CVM Level Time-Points (Days) L2UNCVM1 ૩૯૨ 548 730 l L2UNCVM2 ૩૯૨ રવે જ 730 1 L2UNCVM3 l ૩૯૨ 548 730

Table 2: Stability Protocol Summary

Stability Acceptance Criteria Summary:

The Acceptance Criteria for the IMMULITE 3gAllergy Specific IgE Calibration Verification Material (CVM) are in 2 parts. Part 1 consists of the Guideline acceptance criteria which require dose value of stability calibrator/CVM to fall between ±20% of assigned dose for CVM level 2. ±10% for CVM level 3 and ±15% for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±20% of assiened dose for CVM level 2, ±10% for CVM level 3 and ±15% for CVM level 4, then additional data review is conducted using part 2 criteria.

૩૯૨

548

730

Value Assignment:

L2UNCVM4

The IMMULITE internal calibrators and likewise CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using 3gAllergy Specific IgE antigen stock sourced from Scipac and are traceable to WHO 2nd IRP (75/502). The calibrators/CVMs are manufactured using qualified materials and measurement procedures. The calibrators/CVMs were tested on 27 replicates in total comprised of 9 runs, 8 systems and 3 different reagent kit lots. The Calibrators/CVMs dose values were determined using a curve generated by assigned

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

reference calibrators. The calibrator/CVM values are calculated based on the recovered values for each run on each instrument independently. Calibrator/CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned calibrator/CVM values. The assay controls must fall within their target ranges. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2SD.

Target Mean and Guideline Range:

| CVM (kU/L) | Target
Mean
(kU/L) | SD | Guideline ± 2SD
Range (kU/L) | Precision
(% CV) |
|-------------------------|--------------------------|-------|---------------------------------|---------------------|
| CVM 1 | 0.00 | - | ≤0.10 | N/A |
| CVM 2 | 0.19 | 0.023 | 0.144 - 0.236 | ≤24 |
| CVM 3 | 3.31 | 0.165 | 2.98 - 3.64 | ≤10 |
| CVM 4 | 107* | - | - | - |
| 80% CVM 4,
20% CVM1* | 85.6 | 6.4 | 72.8- 98.4 | ≤15 |
| Assay Range | 0.10 - 100 kU/L | | | |

Table 3: CVM Release Ranges

*Note: CVM 4 (REF L2UNCVM4) requires dilution to ensure the target value is approximately 100 kU/mL, the top of the reportable range of the assay.

Expected Values/Reference Range:

Each laboratory should establish their limits for acceptability based on methodology, clinical significance and medical decision levels of the test analyte. The representative, total precision tabulated in the respective assay instructions for use may be considered as one factor when establishing local, acceptable ranges. The values provided above may be considered as guidelines. Value assignment is lot specific.

d. Detection Limit: Not applicable e. Analytical Specificity: Not applicable f. Assay cut-off: Not applicable

Comparison studies:

a. Method comparison with predicate device: Not applicable

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

b. Matrix comparison:
- Not applicable
1. 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
1. Clinical cut-off:
- Not applicable
1. Expected values/Reference Range:

The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10

O. Conclusion:

The IMMULITE® 2000 Allergy Specific IgE Calibration Verification Material is substantially equivalent to Elecsys IgE CalCheck 5, as demonstrated by results of nonclinical testing, which supports a determination of substantial equivalence.

K133122

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

IMMULITE 2000 Total IgE CVM

510(k) Summary as Required by 21 CFR 807.92

A. 510(k) Number: K133122
B. Purpose for Submission: New device
C. Measurand: Quality Control materials for IMMULITE 2000 Total IgE assay
D. Type of Test:

Calibration Verification Material for IMMULITE 2000 Total IgE assay

E. Applicant:

F. Proprietary and Established Names:

Trade name: IMMULITE® 2000 Total IgE Calibration Verification Material (CVM) Common name: Calibration Verification Material (CVM) Classification name: Single (specified) Analyte Controls (assayed and unassaved)

G. Regulatory Information:

Regulation Section: 21 CFR 862.1660 Classification: Class I (Reserved) Products Code: JJX - Single (specified) Analyte Controls (assayed and unassayed) Panel: Immunology (82)

H. Intended Use / Indications for Use:

1. Intended / Indications for Use

The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is intended for in vitro diagnostic use, as a control for calibration of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

2. Special Conditions for Use:

For prescription use only. For in vitro diagnostic use. The IMMULITE 2000 Total IgE Calibration Verification Material is not intended to be used as a primary calibrator or control material.

3. Special Instrument Requirements:

IMMULITE® 2000 System

I. Device Description:

The IMMULITE 2000 Total IgE Calibration Verification Material (CVM) is supplied frozen in liquid form. It consists of one set of four vials, 3 mL each. LIECVM1 contains equine serum matrix with 0.098% sodium azide and preservatives. LIECVM2, LIECVM3 and LIECVM4 contain various levels of human IgE positive serum in an equine serum matrix with 0.098% sodium azide and preservatives.

J. Substantial Equivalence Information:

Predicate Device name: Elecsys IgE CalCheck 5 Predicate 510(k) number: K102269 Comparison with predicate:

A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 Total IgE Calibration Verification Material (CVM) is substantially equivalent to the predicate device, Elecsys IgE CalCheck 5, as summarized in Table 1.

Table 1: Substantial Equivalence Comparison

SIMILARITIES
	Candidate Device	Predicate Device
	IMMULITE 2000 Total IgE
CVM	Elecsys IgE CalCheck 5
Intended
Use	The IMMULITE 2000 Total IgE
Calibration Verification Material
(CVM) is intended for in vitro
diagnostic use, as a control for
calibration verification of the
IMMULITE 2000 Total IgE
assay on IMMULITE 2000
systems as indicated in the CVM	For use in calibration verification and
for use in the verification of the assay
range established by the Elecsys IgE II
reagent on the indicated Elecsys and
cobas e immunoassay analyzers.

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

SIMILARITIES
	Package Insert.



Analyte	lgE	Same

•
•

	DIFFERENCES
	New Device	Predicate Device
	IMMULITE 2000 Total IgE
CVM	Elecsys IgE CalCheck 5
Form	Liquid	Lyophilized
Levels	4	5
Matrix	Equine Serum	Human Serum
Storage	Unopened: Store at ≤ -20°C until
the expiration date
Opened: Use immediately after
opening. Discard any unused
material.	Unopened: Store at 2-8°C until the
expiration date
Reconstituted: 15-25°C, 4 hours

K. Standard/Guidance Document Referenced:

· CEN 13640 Stability Testing of In Vitro Diagnostic Reagents
· Guidance for Industry and FDA Staff Assayed and Unassayed Ouality Control Material
· Guidance for Industry and FDA Staff Bundling Multiple Devices or Multiple Indications in a Single Submission

L. Test Principle:

Calibration verification is not a requirement of the IMMULITE 2000 system or the IMMULITE 2000 Total IgE assay. CVMs are used by laboratories that wish to document calibration verification as required by certification agencies.

M. Performance Characteristics (if/when applicable):

1. Analytical Performance:
a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range: Not applicable
Not applicable
c. Traceability, Stability, Expected values:

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

Traceability:

The IMMULITE Total IgE CVMs are traceable to WHO 2nd IRP (75/502). The CVMs are manufactured using qualified materials and measurement procedures.

Stability Summary:

The stability study was conducted to validate shelf life claim for the IMMULITE 2000 Total IgE Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULIT:E 2000 systems throughout the established shelf life of the CVM. The IMMULITE® 2000 Total IgE Calibration Verification Materials (CVMs) are stable for up to 4 years when stored at -20℃ prior to opening, supporting the claim of 3.5 years shelf life.

Stability Protocol Summary:

Table 2: Stability Protocol Summary

| CVM Level | Time-Points
(Days) | | | |
|-----------|-----------------------|-----|-----|-----|
| LIECVM1 | 1 | 182 | 365 | 548 |
| LIECVM2 | 1 | 182 | 365 | 548 |
| LIECVM3 | 1 | 182 | 365 | 548 |
| LIECVM4 | 1 | 182 | 365 | 548 |

Stability Acceptance Criteria Summary:

The Acceptance Criteria for the IMMULITE Total IgE Calibration Verification Material (CVM) are in 2 parts. Part 1 consists of the Guideline acceptance criteria which require dose value of stability calibrator/CVM to fall between ±20% of assigned dose for CVM level 2, ±10% for CVM level 3 and ±15% for CVM level 4. Part 2 review limits criteria which require dose value of the controls to be within 2SD of the control target value when generated from the stability calibrator curve. If the result is not within acceptable dose range of ±20% of assigned dose for CVM level 2, ±10% for CVM level 3 and ±15% for CVM level 4, then additional data review is conducted using part 2 criteria.

Value Assignment:

The IMMULITE internal calibrators and likewise CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using Total IgE antigen stock sourced from Bioresource and are traceable to WHO 2nd IRP (75/502). The calibrators/CVMs are manufactured using qualified materials and measurement procedures. The calibrators/CVMs were tested on 27 replicates in total comprised of 9 runs, 8 systems and 5 different reagent kit lots. The Calibrators/CVMs dose values were determined using a curve generated by assigned reference calibrators. The calibrator/CVM values are calculated based on the recovered values

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

for each run on each instrument independently. Calibrator/CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned calibrator/CVM values. The assay controls must fall within their target ranges. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2SD.

Target Mean and Guideline Range:

| CVM (IU/L) | Target Mean
(IU/L) | SD | Guideline ± 2SD
Range (IU/L) | Precision
(% CV) |
|-------------------------|-----------------------|-------|---------------------------------|---------------------|
| CVM 1 | 0.00 | - | ≤1.00 | N/A |
| CVM 2 | 2.91 | 0.3 | 2.3 - 3.5 | ≤20 |
| CVM 3 | 100 | 7.0 | 86.0 - 114 | ≤14 |
| CVM 4 | 2492 | - | - | - |
| 85% CVM 4*
15% CVM 1 | 2065 | 206.5 | 1652 - 2478 | ≤20 |
| Assay Range | 1 - 2000 IU/L | - | - | - |

Table 3: CVM Release Ranges

*Note: CVM 4 (REF LIECVM4) requires dilution to ensure the target value is within +10% of the top of the reportable range of the assay.

Expected Values/Reference Range:

d. Detection Limit: Not applicable e. Analytical Specificity: Not applicable f. Assay cul-off: Not applicable

Comparison studies:

a. Method comparison with predicate device: Not applicable

b. Matrix comparison:

Not applicable

Clinical Studies:

Abbreviated 510(k) Premarket Notification IMMULITE® 2000 3gAllergy Specific IgE and Total IgE CVM 510(k) Summary of Safety and Effectiveness

a. Clinical Sensitivity:

Not applicable

b. Clinical Specificity:

Not applicable

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

Clinical cut-off: Not applicable
Expected values/Reference Range:

The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10

O. Conclusion:

The IMMULITE® 2000 Total IgE Calibration Verification Material is substantially equivalent to Elecsys IgE CalCheck 5, as demonstrated by results of non-clinical testing, which supports a determination of substantial equivalence.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is black and white.

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

October 30, 2013

SIEMENS HEALTHCARE DIAGNOSTICS, INC. C/O MS. SUSAN BROCCHI, RAC SENIOR REGULATORY AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591-0597

Re: K133122

Trade/Device Name: IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) and IMMULITE 2000 Total IgE Calibration Verification Material (CVM)

Regulation Number: 21 CFR 862.1660

Regulation Name: Quality control material (assayed and unassayed)

Regulatory Class: I

Product Code: JJX

Dated: September 27, 2013 Received: September 30, 2013

Dear Ms. Brocchi:

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 II (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

Page 2-Ms. Brocchi

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Reena Philip -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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number: K133122

Device Name

IMMULITE® 2000 3gAllergy™ Specific IgE Calibration Verification Material

Indications for Use (Describe)

The IMMULITE 2000 3gAllergy Specific IgE Calibration Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 3gAllergy Specific IgE assay on IMMULITE 2000 systems as indicated in the CVM Package Insert.

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

Z Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

FOR FDA USE ONLY

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

Elizabeth A. Stafford信息公

FORM FDA 3881 (6/13)

PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number: K133122

Device Name

IMMULITE® 2000 Total IgE Calibration Verification Material

Indications for Use (Describe)

The IMMULITE 2000 Total IgE Calibration Material (CVM) is intended for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Total IgE assay on IMMULITE 2000 systems as indicated in the CVM 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 807 Subpart C)

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

FOR FDA USE ONLY

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

Elizabeth A. Stafford); S

FORM FDA 3881 (6/13)

PSC Publishing Scrivices (301) 443-6140 EF