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.

AI/ML Overview

This document describes the IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM) and the IMMULITE 2000 Total IgE Calibration Verification Material (CVM). Both are intended for in vitro diagnostic use as controls for calibration verification of their respective IMMULITE 2000 assays.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

There are two separate products described in this 510(k) submission: the IMMULITE 2000 3gAllergy Specific IgE CVM and the IMMULITE 2000 Total IgE CVM. Both have similar acceptance criteria for stability.

IMMULITE 2000 3gAllergy Specific IgE Calibration Verification Material (CVM)

CVM Level	Acceptance Criteria (Guideline)	Reported Performance (Stability Summary)
CVM Level 2	Dose value between ±20% of assigned dose	Stable for up to 1.5 years when stored at -20°C prior to opening. (Specific dose values not provided for the stability study, but the summary implies compliance with these criteria.)
CVM Level 3	Dose value between ±10% of assigned dose	Stable for up to 1.5 years when stored at -20°C prior to opening.
CVM Level 4	Dose value between ±15% of assigned dose	Stable for up to 1.5 years when stored at -20°C prior to opening.
All CVM Levels	If Part 1 criteria not met, dose value of controls within 2SD of control target value (Part 2 review limits)	Implied compliance through successful stability study and statement of optimal product performance.

IMMULITE 2000 Total IgE Calibration Verification Material (CVM)

CVM Level	Acceptance Criteria (Guideline)	Reported Performance (Stability Summary)
CVM Level 2	Dose value between ±20% of assigned dose	Stable for up to 4 years when stored at -20°C prior to opening, supporting a 3.5 year shelf life claim. (Specific dose values not provided for the stability study, but the summary implies compliance with these criteria.)
CVM Level 3	Dose value between ±10% of assigned dose	Stable for up to 4 years when stored at -20°C prior to opening, supporting a 3.5 year shelf life claim.
CVM Level 4	Dose value between ±15% of assigned dose	Stable for up to 4 years when stored at -20°C prior to opening, supporting a 3.5 year shelf life claim.
All CVM Levels	If Part 1 criteria not met, dose value of controls within 2SD of control target value (Part 2 review limits)	Implied compliance through successful stability study and statement of optimal product performance.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" for performance evaluation appears to be the samples used in the stability studies and value assignment processes.

For both CVMs (3gAllergy Specific IgE and Total IgE):
- Sample Size: The calibrators/CVMs were tested on 27 replicates in total, comprised of 9 runs, 8 systems, and (for 3gAllergy Specific IgE) 3 different reagent kit lots, and (for Total IgE) 5 different reagent kit lots. The stability protocols state CVMs are run in duplicate (as a minimum) at specified time points (e.g., 1, 182, 365, 548, 730 days).
- Data Provenance: Not explicitly stated as "country of origin" but implies retrospective testing of manufactured CVMs over time to assess stability. The manufacturing location of Siemens Healthcare Diagnostics Inc. is Tarrytown, NY, USA, which usually indicates the data is generated within the US or a facility overseen by the US entity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not Applicable. This submission is for Calibration Verification Materials, not for a diagnostic device that requires expert interpretation of results. The "ground truth" for these materials is established through analytical methods and traceability to international standards (WHO 2nd IRP (75/502)).

4. Adjudication Method for the Test Set

Not Applicable. As this is an analytical device for calibration verification, there's no "adjudication" in the sense of resolving discrepancies between human interpretations or diagnostic outcomes. The performance is assessed against predefined analytical acceptance criteria. The "Part 2 review limits criteria" (dose value of controls within 2SD of the control target value) act as an internal review mechanism, but it's not and adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a quality control material and not a diagnostic device involving human readers or interpretation of complex cases. Therefore, an MRMC comparative effectiveness study is not applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

Yes, in essence. The performance studies conducted (stability, value assignment) evaluate the analytical performance of the CVMs themselves in conjunction with the IMMULITE 2000 system, without human interpretation of results influencing the CVM's "performance" at a diagnostic level. The CVM is an "algorithm only" device in a metaphorical sense, as its function is to provide expected values for system calibration verification.

7. The Type of Ground Truth Used

Traceability to International Reference Standards: The "ground truth" for the assigned values of the CVMs is their traceability to the WHO 2nd IRP (75/502). This is an international reference preparation for IgE, providing a recognized standard for quantifying IgE concentrations. The assigned reference calibrators are also prepared using specific antigen stocks (Scipac for 3gAllergy Specific IgE, Bioresource for Total IgE) which are traceable to this WHO standard.

8. The Sample Size for the Training Set

Not Applicable/Not Explicitly Defined as "Training Set": For a calibration verification material, there isn't a "training set" in the typical machine learning sense. However, the value assignment process for the CVMs involves extensive testing to establish the target mean and guideline ranges. This process is akin to establishing reference data.
- For both CVMs: The calibrators/CVMs were tested on 27 replicates in total comprised of 9 runs, 8 systems, and 3 or 5 different reagent kit lots. This rigorous testing helps "train" or establish the expected performance parameters for the CVMs.

9. How the Ground Truth for the Training Set Was Established

Traceability and Extensive Analytical Testing: The "ground truth" (assigned values, target means, and guideline ranges) for the value assignment process was established using:
- Assigned Reference Calibrators: These are prepared using specific IgE antigen stock traceable to the WHO 2nd IRP (75/502).
- Qualified Materials and Measurement Procedures: The CVMs are manufactured and tested using these throughout.
- Statistical Analysis of Multiple Replicates: Dose values were determined from reference calibrator curves, and calibrator/CVM values were calculated based on recovered values for each run on each instrument independently, then averaged across all systems. Quality control ensures assay controls fall within target ranges. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2SD from this extensive testing.

In summary, the studies conducted focus on the analytical performance, specifically the stability and accurate value assignment of these calibration verification materials, rather than clinical diagnostic accuracy or reader performance studies.

Summary

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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)

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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 AllergySpecific IgE CVM	Elecsys IgE CalCheck 5
IntendedUse	The IMMULITE2000 3gAllergy Specific IgECalibration Verification Material(CVM) is intended for in vitrodiagnostic use, as a control forcalibration verification of theIMMULITE 2000 3gAllergy	For use in calibration verification andfor use in the verification of the assayrange established by the Elecsys IgE IIreagent on the indicated Elecsys andcobas e immunoassay analyzers.

Table 1: Substantial Equivalence Comparison

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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 onIMMULITE 2000 systems asindicated in the CVM PackageInsert.
Analyte	IgE	Same

	DIFFERENCES
	New Device	Predicate Device
	IMMULITE 2000 AllergySpecific IgE CVM	Elecsys IgE CalCheck 5
Form	Liquid	Lyophilized
Levels	4	5
Matrix	Equine Serum	Human Serum
Storage	Unopened: Store at ≤ -20°C untilthe expiration dateOpened: Use immediately afteropening. Discard any unusedmaterial.	Unopened: Store at 2-8°C until theexpiration dateReconstituted: 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:

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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

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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)	TargetMean(kU/L)	SD	Guideline ± 2SDRange (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

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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.

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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)

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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 IgECVM	Elecsys IgE CalCheck 5
IntendedUse	The IMMULITE 2000 Total IgECalibration Verification Material(CVM) is intended for in vitrodiagnostic use, as a control forcalibration verification of theIMMULITE 2000 Total IgEassay on IMMULITE 2000systems as indicated in the CVM	For use in calibration verification andfor use in the verification of the assayrange established by the Elecsys IgE IIreagent on the indicated Elecsys andcobas e immunoassay analyzers.

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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 IgECVM	Elecsys IgE CalCheck 5
Form	Liquid	Lyophilized
Levels	4	5
Matrix	Equine Serum	Human Serum
Storage	Unopened: Store at ≤ -20°C untilthe expiration dateOpened: Use immediately afteropening. Discard any unusedmaterial.	Unopened: Store at 2-8°C until theexpiration dateReconstituted: 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:

{9}------------------------------------------------

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

{10}------------------------------------------------

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 ± 2SDRange (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:

{11}------------------------------------------------

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.

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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

{13}------------------------------------------------

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

{14}------------------------------------------------

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

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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: 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

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.