K Number

Device Name

IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

Date Cleared

2014-03-05

(30 days)

Product Code

JJX

Regulation Number

862.1660

Intended Use

The IMMULITE 2000 DHEA-SO4 Calibration Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE DHEA-SO4 assay on the IMMULITE 2000 systems. The IMMULITE 2000 Third Generation Verification Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Third Generation TSH assay on the IMMULITE 2000 systems. The IMMULITE 2000 Intact PTH Calibration Material (CVM) is intended for in vitro diagnostic use in the verification of calibration of the IMMULITE Intact PTH assay on the IMMULITE 2000 systems.

Device Description

The Calibration Verification Material (CVM) contains one set of four vials each 2.0mL after reconstitution. CVM1 contains human serum with preservatives. CVM2, CVM 3 and CVM4 contain various levels of lyophilized DHEA-SO4 in human serum with preservatives. The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each after reconstitution. CVM 1 contains an equine serum/buffer matrix with preservatives. CVM2. CVM3 and CVM4 various levels of lyophilized TSH in an equine serum/buffer matrix with preservatives. The Calibration Verification Material (CVM) contains one set of four vials, with 4 mL for CVM1 and 2 mL each for CVM2, CVM3 and CVM4 after reconstitution. CVM1 contains a buffered bovine protein matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of lyophilized synthetic human intact PTH in buffered bovine protein matrix with preservatives.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K133128

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly indicate that this is a calibration verification material for laboratory assays, not a software or system that would typically incorporate AI/ML for analysis or decision-making. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and the performance studies described are standard for calibration materials.

Therapeutic

No
The device is an in vitro diagnostic device used to verify the calibration of assays, which means it is used in laboratory testing, not in the treatment of patients.

Diagnostic

Yes
The text explicitly states "The IMMULITE 2000 DHEA-SO4 Calibration Material (CVM) is intended for in vitro diagnostic use". This phrase "in vitro diagnostic use" clearly tags the device as a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly states that the device is a "Calibration Verification Material (CVM)" which contains vials of human or equine serum with preservatives and lyophilized substances. This indicates a physical, chemical-based product, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use explicitly states "intended for in vitro diagnostic use". This is the primary indicator.
Device Description: The device is a "Calibration Verification Material (CVM)" which is used to verify the calibration of diagnostic assays (IMMULITE DHEA-SO4 assay, IMMULITE Third Generation TSH assay, IMMULITE Intact PTH assay). These assays are themselves IVDs used to measure substances in biological samples (serum).
Intended User/Care Setting: "For prescription use only" suggests use in a clinical or laboratory setting, consistent with IVDs.
Predicate Device: The predicate device listed (K133128 IMMULITE™ 2000 Insulin Calibration Verification Material (CVM)) is also a calibration verification material for an IMMULITE assay, further supporting the IVD classification.

The device is a component used in the process of performing in vitro diagnostic tests, specifically for ensuring the accuracy of the calibration of those tests. Therefore, it falls under the definition of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMMULITE® DHEA-SO4 Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE DHEA-SO4 assay on the IMMULITE 2000 systems.
The IMMULITE® Third Generation TSH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Third Generation TSH assay on the IMMULITE 2000 systems
The IMMULITE® Intact PTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Intact PTH assay on the IMMULITE 2000 systems

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

JJX

Device Description

The Calibration Verification Material (CVM) contains one set of four vials, 3 mL each after reconstitution. CVM 1 contains an equine serum/buffer matrix with preservatives. CVM2. CVM3 and CVM4 various levels of lyophilized TSH in an equine serum/buffer matrix with preservatives.

The Calibration Verification Material (CVM) contains one set of four vials, with 4 mL for CVM1 and 2 mL each for CVM2, CVM3 and CVM4 after reconstitution. CVM1 contains a buffered bovine protein matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of lyophilized synthetic human intact PTH in buffered bovine protein matrix with 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

For prescription use only

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

Not Found

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

Not Found

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

DHEA-SO4 CVM:
Stability study: Real-time shelf life and In-Use (Open Component or open vial) stability.
Shelf life: Up to 7 years when stored at -20°C prior to opening.
In-use stability: 8 hours at ambient or room temperature (15-25°C) after reconstitution.
Time-points: 1, 1642, 1825, 2555 days.
Acceptance Criteria: Dose value between ±15% of assigned dose for CVM level 2, ±10% for level 3, and ±15% for level 4. Controls within 2SD of target value.
Value Assignment: 27 replicates (9 runs, 3 replicates per run) on 9 systems with 4 different reagent kit lots.
Traceability: Internal material, gravimetrically prepared.

Third Generation TSH CVM:
Stability study: Real-time shelf life and In-Use (Open Component or open vial) stability.
Shelf life: Up to 1.5 years when stored frozen at -20°C prior to opening.
In-use stability: 8 hours at ambient or room temperature (15-25°C) after reconstitution.
Time-points: 1, 182, 365, 548 days.
Acceptance Criteria: Dose value between ±10% of assigned dose for CVM level 2, ±12% for level 3, and ±16% for level 4. Controls within 2SD of target value.
Value Assignment: 15 replicates (5 runs, 3 replicates per run) on 5 systems with 5 different reagent kit lots.
Traceability: WHO 2nd IRP 80/558.

Intact PTH CVM:
Stability study: Real-time shelf life and In-Use (Open Component or open vial) stability.
Shelf life: Up to 2 years when stored at -20°C prior to opening.
In-use stability: 8 hours at ambient or room temperature (15-25°C) after reconstitution.
Time-points: 1, 182, 365, 730 days.
Acceptance Criteria: Dose value between ±12% of assigned dose for CVM level 2, ±8% for level 3, and ±12% for level 4. Controls within 2SD of target value.
Value Assignment: 27 replicates (9 runs) on 7 systems with 3 different reagent kit lots.
Traceability: Internal material, gravimetrically prepared.

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

DHEA-SO4 CVM:
CVM Level 2: ±15% difference to assigned dose
CVM Level 3: ±10% difference to assigned dose
CVM Level 4: ±15% difference to assigned dose
Controls are within 2SD of target on each curve.

Third Generation TSH CVM:
CVM Level 2: ±10% difference to assigned dose
CVM Level 3: ±12% difference to assigned dose
CVM Level 4: ±16% difference to assigned dose
Controls are within 2SD of target on each curve.

Intact PTH CVM:
CVM Level 2: ±12% difference to assigned dose
CVM Level 3: ±8% difference to assigned dose
CVM Level 4: ±12% difference to assigned dose
Controls are within 2SD of target on each curve.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K133128

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

MAR - 5 2014

Section 006: 510(k) Summary

510(k) Summary

Introduction: According to the requirements of 21 CFR 807.92, the following information provides
sufficient details to understand the basis for determination of substantial

长140258 The assigned 510(k) Number: _

| 1.
Submitter
Mailing Address: | | Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591 | | |
|-------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | Contact Person:
Phone Number:
Fax Number:
E-mail Address:
Date Prepared: | Asha Gartland
Technical Regulatory Affairs Specialist
(914)-524-3257
(914)-524-2101
asha.gartland@siemens.com
January 31, 2014 | | |
| | 2. Device Name
Proprietary Name:
Measurand:
Type of Test: | IMMULITE® 2000 DHEA-SO4 Calibration Verification Material
Quality Control materials for IMMULITE® 2000 DHEA-SO4 assay
Calibration Verification Material (CVM) for IMMULITE® 2000
DHEA-SO4 assay | | |
| | Regulation Section:
Classification :
Products Code:
Panel: | 21 CFR 862.1660, Quality Control Material
Class I Reserved
JJX - Single (Specified) Analyte Controls (Assayed and Unassayed)
Clinical Chemistry (75) | | |
| | 3. Predicate Device Name
Predicate 510(k) No: | IMMULITE™ 2000 Insulin Calibration Verification Material (CVM)
K133128 | | |
| | 4. Device Description: | The Calibration Verification Material (CVM) contains one set of four
vials each 2.0mL after reconstitution. CVM1 contains human serum
with preservatives. CVM2, CVM 3 and CVM4 contain various levels
of lyophilized DHEA-SO4 in human serum with preservatives. | | |
| | 5. Intended Use:
Indication for Use: | See Indications for Use Statement below:
The IMMULITE® DHEA-SO4 Calibration Verification Material
(CVM) is for in vitro diagnostic use in the verification of calibration
of the IMMULITE DHEA-SO4 assay on the IMMULITE 2000
systems. | | |

Special Conditions for Use Statement(s): Special Instrument Requirements:

1. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
  For prescription use only

IMMULITE® 2000 Systems

A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 DHEA-SO4 Calibration Verification Material (CVM) is substantially cquivalent to the predicate device as summarized in Table 1.

Table 1: Substantial Equivalence Comparison

SIMILARITIES
	Candidate Device
IMMULITE 2000 DHEA-SO4 CVM	Predicate Device
IMMULITE 2000 Insulin CVM
Intended
Use	The IMMULITE® DHEA-SO4
Calibration Verification Material (CVM) is
for in vitro diagnostic use in the
verification of calibration of the
IMMULITE DHEA-SO4 assay on the
IMMULITE 2000 systems.	The IMMULITE® Insulin Calibration
Verification Material (CVM) is for in
vitro diagnostic use in the verification of
calibration of the IMMULITE Insulin
assay on the IMMULITE 2000 systems.
Form	Lyophilized	Same
Levels	4	Same
Storage	≤20°C	Same
Stability	Stable unopened until the expiration date	Same
Use	Single Use Only	Same

	DIFFERENCES
	Candidate Device
IMMULITE 2000 DHEA-SO4 CVM	Predicate Device
IMMULITE 2000 Insulin CVM
Analyte	DHEA-SO4	Insulin
Matrix	Human Serum with preservatives	Equine serum with preservatives

7. Non-Clinical Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the candidate device.

7.1 Stability Summary:

The stability study was conducted to validate the real-time shelf life and In-Use (Open Component or open vial) claim for the IMMULITE 2000 DHEA-SO4 Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM before and after opening. The IMMULITE® 2000 DHEA-SO4 Calibration Verification Materials are stable up to 7 years when stored at -20°C prior to opening and stable for 8 hours at ambient or room temperature (15-25°C) after reconstitution.

7.1.1 Stability Protocol Summary:

The CVM study protocols are run as part of the calibrator stability testing. The stability CVMs and reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 2 and the dose value determined from the reference calibrator curve.

CVM Level	Time-Points (Days)
LDSCVM1	1	1642	1825	2555
LDSCVM2	1	1642	1825	2555
LDSCVM3	1	1642	1825	2555
LDSCVM4	1	1642	1825	2555

Table 2: Stability Time Points

For Open Component testing, the results are determined from a 2-point adjustment. Test CVMs were tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.

7.1.2 Stability Acceptance Criteria Summary:

The Acceptance Criteria for the DHEA-SO4 Calibration Verification Material (CVM) are in 2 parts. Part 1 consists of guideline acceptance criteria which require dose value of stability calibrators/CVM to fall between ±15% of assigned dose for CVM level 2, ±10% of assigned dose for level 3 and ±15% of assigned dose for 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 ±15% for CVM level 2, ±10% for level 3 and ±15% for level 4 then additional data review is conducted using part 2 criteria.

The acceptance criterion is summarized in Table 3.

CVM Level	Assigned Dose (µg/dL)	*Guideline Criteria % difference to assigned dose	Acceptable dose range (µg/dL)	**Review Limits
LDSCVM1	0.00	Not Applicable	Not Applicable	Controls are within 2SD of target on each curve
LDSCVM2	46.9	$\pm$ 15%	39.9 - 53.9
LDSCVM3	486	$\pm$ 10%	437.4 - 534.6
LDSCVM4	1052	$\pm$ 15%	894.2 - 1209.8

Table 3 Acceptance criteria for stability of IMMULITE 2000 DHEA-SO4 CVM

7.2 Traceability:

The IMMULITE DHEA-SQ CVMs are traceable to an internal material which has been gravimetrically prepared. The CVMs are manufactured using qualified materials and measurement procedures.

7.3 Value Assignment:

DHEA-SO4 CVMs are 4 level materials which are a subset of 7 level DHEA-SO4 calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of DHEA-SO4 reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using DHEA-SO4 antigen stock and are traccable to an internal material which has been gravimetrically prepared. Six levels of commercially available controls and 30 normal serum samples were used to validate calibrator/CVM value assignments.

The CVMs are manufactured using qualified materials and measurement procedures. The DHEA-SO4 CVMs were tested on 27 replicates in total comprised of 9 runs, 3 replicates per run, on 9 systems and 4 different reagent kit lots. The CVMs dose values are generated using curve generated by assigned reference calibrators. The CVM values are calculated based on the recovered values for each run on cach instrument independently. CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples and controls using the assigned CVM values. The controls must fall within their target ranges.

7.4 Expected Values/Reference Range:

Each CVM level was tested on 27 replicates in total comprised of 9 runs, 3 replicates per run, on 9 systems and 4 different reagent kit lots. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expected values are provided in the IMMULITE® 2000 CVM Calibration verification Material lot-specific package insert.

The expected assay range is 1 - 1000 µg/dL. The target values in Table 4 can be considered as guidelines.

| Analyte
target levels | CVM Level | Target Mean
(µg/dL) | Standard
Deviation
(SD) | Guideline ±2SD Range
(µg/dL) |
|--------------------------|----------------|------------------------|-------------------------------|---------------------------------|
| | CVM1 | 0.00 | - | 0.00 $≤$ 15.00 |
| | CVM2 | 46.9 | 6.1 | 34.7 59.1 |
| | CVM3 | 486 | 43.5 | 399 573 |
| | CVM4 | 1052 | 84 | 884 1220 |
| Assay Range | 1 - 1000 µg/dL | | | |

Table 4: Target Values

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.

Standard/Guidance Documents Referenced:

CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
Guidance for Industry Abbreviated 510(k) Submissions for In Vitro Diagnostic . Calibrators
Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control . Material

Proposed Labeling:

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

8. Conclusion:

The IMMULITE® 2000 DHEA-SO4 Calibration Verification Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the FDA cleared IMMULITE® 2000 Insulin Calibration Verification Material. The substantial equivalence of the device is supported by the non-clinical testing and was found to be comparable and supports the claims of substantial equivalence, product safety and effectiveness. Based on the testing completed and the comparisons with predicate device, the IMMULITE® 2000 DHEA-SO4 Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.

510(k) Summary

Introduction: According to the requirements of 21 CFR 807.92, the following information provides sufficient details to understand the basis for determination of substantial equivalence. The assigned 510(k) Number: _______________________________________

1. Submitter
Mailing Address:	Siemens Healthcare Diagnostics Inc.
	511 Benedict Avenue
	Tarrytown, NY 10591
Contact Person:	Asha Gartland
	Technical Regulatory Affairs Specialist
Phone Number:	(914)-524-3257
Fax Number:	(914)-524-2101
E-mail Address:	asha.gartland@siemens.com
Date Prepared:	January 31st, 2014
2. Device Name
Proprietary Name:	IMMULITE® 2000 Third Generation TSH Calibration
Measurand:	Verification Material
Type of Test:	Quality Control materials for IMMULITE® 2000 Third Generation
TSH assay
	Calibration Verification Material (CVM) for IMMULITE® 2000
Third Generation TSH assay
Regulation Section:	21 CFR 862.1660, Quality Control Material
Classification:	Class I Reserved
Products Code:	JJX – Single (Specified) Analyte Controls (Assayed and Unassayed)
Panel:	Clinical Chemistry (75)

3. Predicate Device Name	IMMULITE® 2000 Insulin Calibration Verification Material (CVM)
Predicate 510(k) No:	K133128
4. Device Description:	The Calibration Verification Material (CVM) contains one set of four
vials, 3 mL each after reconstitution. CVM 1 contains an equine
serum/buffer matrix with preservatives. CVM2. CVM3 and CVM4
various levels of lyophilized TSH in an equine serum/buffer matrix
with preservatives.

Intended Use: Indication for Use: See Indications for Use Statement below The IMMULITE® Third Generation TSH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Third Generation TSH assay on the IMMULITE 2000 systems

Special Conditions for Use Statement(s): Special Instrument Requirements:

For prescription use only

IMMULITE® 2000 Systems

Technological Characteristics and Substantial Equivalence Comparison with Predicate:

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

Table 1: Substantial Equivalence Comparison
---------------------------------------------	--

SIMILARITIES
Candidate Device
IMMULITE 2000 Third Generation
TSH CVM	Predicate Device
IMMULITE 2000 Insulin CVM
Intended Use	The IMMULITE® Third Generation
TSH Calibration Verification Material
(CVM) is for in vitro diagnostic use in
the verification of calibration of the
IMMULITE Third Generation TSH
assay on the IMMULITE 2000 systems	The IMMULITE® Insulin
Calibration Verification Material
(CVM) is for in vitro diagnostic use
in the verification of calibration of the
IMMULITE Insulin assay on the
IMMULITE 2000 systems
Form	Lyophilized	Same
Matrix	Equine serum/buffer with preservatives	Same
Storage	≤20°C	Same
Stability	Stable unopened until the expiration date	Same
Levels	4	Same
Use	Single Use Only	Same

DIFFERENCES
Candidate Device
IMMULITE 2000 Third Generation TSH
CVM		Predicate Device
IMMULITE 2000 Insulin CVM
Analyte	TSH	Insulin

7. Non-Clinical Performance Testing

Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the candidate device.

7.1 Stability Summary:

The stability study was conducted to validate the real-time shelf life and In-Use (Open Component or open vial) claim for the IMMULITE 2000 Third Generation TSH Calibration Verification Material (CVM) to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the CVM before and after The IMMULITE 2000 Third Generation TSH Calibration Verification Materials are opening. stable up to 1.5 years when stored frozen at -20°C prior to opening and stable for 8 hours at ambient or room temperature (15-25℃) after reconstitution.

7.1.1 Stability Protocol Summary:

Table 2: Stability Time Points

CVM Level	Time-Points (Days)
LTSCVM1	1	182	365	548
LTSCVM2	1	182	365	548
LTSCVM3	1	182	365	548
LTSCVM4	1	182	365	548

For Open Component testing, the results are determined from a 2-point adjustment. Test CVMs were tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.

7.1.2 Stability Acceptance Criteria Summary:

The Acceptance Criteria for the Third Generation TSH Calibration Verification Material (CVM) are in 2 parts. Part 1 consists of guideline acceptance criteria which require dose value of stability calibrators/CVM to fall between ±10% of assigned dose for CVM level 2, ±12% of assigned dose for level 3 and ±16% of assigned dose for 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 ±10% for CVM level 2, ±12% for level 3 and ±16% for level 4 then additional data review is conducted using part 2 criteria. The acceptance criterion is summarized in Table 3.

Table 3: Acceptance criteria for stability of IMMULITE 2000 Third Generation TSH CVM

| CVM level | Assigned
Dose
(µIU/mL) | Guideline Criteria
% difference to assigned
dose | Acceptable dose range
(µIU/mL) | Review
Limits |
|-----------|------------------------------|--------------------------------------------------------|-----------------------------------|----------------------------------------------------------|
| LTSCVM1 | 0 | Not Applicable | Not Applicable | Controls are
within 2SD
of target on
each curve |
| LTSCVM2 | 0.58 | ±10% | 0.52 - 0.64 | Controls are
within 2SD
of target on
each curve |
| LTSCVM3 | 4.33 | ±12% | 3.81 - 4.85 | Controls are
within 2SD
of target on
each curve |
| LTSCVM4 | 75 | ±16% | 63.00 - 87.00 | Controls are
within 2SD
of target on
each curve |

7.2 Traceability:

The IMMULITE Third Generation TSH CVMs are traceable to WHO 2nd IRP 80/558. The CVMs are manufactured using qualified materials and measurement procedures.

7.3 Value Assignment:

Third Generation TSH CVMs are 4 level materials which are a subset of 15 level Third Generation TSH calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Third Generation TSH reagents and two point adjustors. The IMMULITE calibrators and therefore CVMs are value assigned using assigned reference calibrators. The assigned reference calibrators are prepared using human TSH antigen spiked in Equine Serum matrix with preservatives. Seven levels of commercially available controls and 30 samples (10 spiked patient samples, 15 spiked normal samples and 5 normal samples were used to validate calibrator/CVM value assignments.

The CVMs are manufactured using qualified materials and measurement procedures. The calibrators/CVMs were tested on 15 replicates in total comprised of 5 runs, 3 replicates per run, on 5 systems and 5 different reagent kit lots. The CVMs dose values are generated using curve generated by assigned reference calibrators. The CVM values are calculated based on the recovered values for each run on each instrument independently. CVM values are then averaged across all systems. Quality control is performed by calculating the recovery of patient samples, spiked patient samples and controls using the assigned CVM values. The controls must fall within their target ranges.

7.4 Expected Values/Reference Range:

Each CVM level was tested on 15 replicates in total comprised of 5 runs, 3 replicates per run, on 5 systems and 5 different reagent kit lots. The Guideline Range (95% confidence interval) for each CVM level was established based on the Target Mcan and ± 2 Standard Deviation (SD). The expected values are provided in the 1MMULITE® 2000 CVM Calibration Verification Material lot-specific package insert The expected assay range is 0.004 - 75 uIU/mL. The target values in Table 4 can be considered as guidelines.

| Analyte target
levels | CVM Level | Target
(µIU/mL) | Standard
Deviation
(SD) | Guideline ±2SD
Range
(µIU/mL) |
|--------------------------|-------------------|--------------------|-------------------------------|-------------------------------------|
| | CVM1 | 0.000 | - | 0.000 0.004 |
| | CVM2 | 0.580 | 0.032 | 0.516 0.644 |
| | CVM3 | 4.33 | 0.26 | 3.81 4.85 |
| | CVM4 | 75.0 | 6.0 | 63.0 87.0 |
| Assay Range | 0.004 - 75 µIU/mL | | | |

		Table 4: Target Values
--	--	------------------------

Standard/Guidance Documents Referenced:

CEN 13640 Stability Testing of In Vitro Diagnostic Reagents .
Guidance for Industry -- Abbreviated 510(k) Submissions for In Vitro Diagnostic . Calibrators
Guidance for Industry and FDA Staff Assayed and Unassayed Quality Control . Material

Proposed Labeling:

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

Conclusion: 8.

The IMMULITE® 2000 Third Generation TSH Calibration Verification Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the FDA cleared IMMULITE® 2000 Insulin Calibration Verification Material. The substantial equivalence of the device is supported by the non-clinical testing and was found to be comparable and supports the claims of substantial equivalence, product safety and effectiveness. Based on the testing completed and the comparisons with predicate device, the IMMULITE® 2000 Third Generation TSH Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.

510(k) Summary

1. Submitter	Siemens Healthcare Diagnostics Inc.
Mailing Address:	511 Benedict Avenue
Tarrytown, NY 10591
Contact Person:	Asha Gartland
	Technical Regulatory Affairs Specialist
Phone Number:	(914)-524-3257
Fax Number:	(914)-524-2101
E-mail Address:	asha.gartland@siemens.com
Date Prepared:	January 31, 2014
2. Device Name	IMMULITE® 2000 Intact PTH Calibration Verification
Proprietary Name:	Material
Measurand:	Quality Control materials for IMMULITE® 2000 Intact PTH assay
Type of Test:	Calibration Verification Material (CVM) for IMMULITE® 2000
Intact PTH assay
Regulation Section:	21 CFR 862.1660, Quality Control Material
Classification:	Class I Reserved
Products Code:	JJX – Single (Specified) Analyte Controls (Assayed and
Unassayed)
Panel:	Clinical Chemistry (75)
3. Predicate Device Name	IMMULITE® 2000 Insulin Calibration Verification Material
(CVM) K133128
Predicate 510(k) No:
4. Device Description:	The Calibration Verification Material (CVM) contains one set of
four vials, with 4 mL for CVM1 and 2 mL each for CVM2, CVM3
and CVM4 after reconstitution. CVM1 contains a buffered bovine
protein matrix with preservatives. CVM2, CVM3 and CVM4
contain various levels of lyophilized synthetic human intact PTH
in buffered bovine protein matrix with preservatives.

Comparison with Predicate:

See Indications for Use Statement below 5. Intended Use: Indication for Use: The IMMULITE® Intact PTH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Intact PTH assay on the IMMULITE 2000 systems Special Conditions for For prescription use only Use Statement(s): IMMULITE® 2000 Systems Special Instrument Requirements: A comparison of the device features, intended use, and other 6. Technological information demonstrates that the IMMULITE® 2000 Intact PTH Characteristics and Calibration Verification Material (CVM) is substantially Substantial Equivalence equivalent to the predicate device as summarized in Table 1.

Table 1: Substantial Equivalence Comparison

SIMILARITIES
	Candidate Device
IMMULITE 2000 Intact PTH CVM	Predicate Device
IMMULITE 2000 Insulin CVM
Intended
Use	The IMMULITE® Intact PTH Calibration
Verification Material (CVM) is for in
vitro diagnostic use in the verification of
calibration of the IMMULITE Intact PTH
assay on the IMMULITE 2000 systems.	The IMMULITE® Insulin
Calibration Verification Material
(CVM) is for in vitro diagnostic use
in the verification of calibration of
the IMMULITE Insulin assay on the
IMMULITE 2000 systems.
Form	Lyophilized	Same
Levels	4	Same
Stability	Stable unopened until the expiration date	Same
Use	Single Use Only	Same
Storage