K Number

Device Name

IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)

Manufacturer

Siemens Healthcare Diagnostics Inc.

Date Cleared

2014-10-29

(30 days)

Product Code

JJX

Regulation Number

862.1660

Intended Use

The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems. The IMMULITE® 2000 Free T3 Calbration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T3 assay on the IMMULITE 2000 systems The IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Gastrin assay on the IMMULITE 2000 systems

Device Description

The IMMULITE 2000 LH Calibration Verification Material (CVM) contains one set of four vials each 3.0mL after reconstitution. CVM1 contains lyophilized bovine serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of LH antigen from human pituitary glands in a lyophilized bovine serum matrix with preservatives. IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) contains one set of four vials. CVM1 contains 4.0 mL processed lyophilized human serum with preservatives after reconstitution. CVM2, CVM3 and CVM4 contain 2.0mL/vial of various levels of 3,31 Triiodo-L-Thyronine (Free Acid) in processed lyophilized human serum with preservatives after reconstitution. The IMMULITE 2000 Gastrin Calibration Verification Material (CVM) contains one set of four vials, 2.0 mL each after reconstitution. CVM1 contains a lyophilized processed buffered human protein matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of synthetic-human gastrin in a lyophilized processed buffered human 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

K140258, K133128

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a calibration verification material, which is a reagent used to check the accuracy of an assay on a specific instrument. The description focuses on the composition and performance of the material itself, with no mention of AI or ML in its function or the analysis of results.

Therapeutic

No
This device is for in vitro diagnostic use, specifically for the verification of calibration of assays on IMMULITE 2000 systems, not for direct therapeutic treatment of a patient.

Diagnostic

The device is a "Calibration Verification Material" (CVM) used to verify the calibration of an IMMULITE LH, Free T3, or Gastrin assay on IMMULITE 2000 systems. It is not an assay or system that directly diagnoses a patient's condition.

SaMD (Software as a Medical Device)

The device description clearly states that the device is a material (lyophilized bovine serum, human serum, etc.) in vials, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states that the materials are "for in vitro diagnostic use". This is the primary indicator that the device falls under the category of IVDs.

Furthermore, the device is intended to be used in a laboratory setting ("on the IMMULITE 2000 systems") to verify the calibration of assays that measure analytes (LH, Free T3, Gastrin) in biological samples. This function aligns with the definition of an IVD, which is a device intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems.

The IMMULITE® 2000 Free T3 Calibration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T3 assay on the IMMULITE 2000 systems

The IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Gastrin assay on the IMMULITE 2000 systems

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

JJX

Device Description

IMMULITE® 2000 LH Calibration Verification Material (CVM): The IMMULITE 2000 LH Calibration Verification Material (CVM) contains one set of four vials each 3.0mL after reconstitution. CVM1 contains lyophilized bovine serum with preservatives. CVM2, CVM3 and CVM4 contain various levels of LH antigen from human pituitary glands in a lyophilized bovine serum matrix with preservatives.

IMMULITE® 2000 Free T3 Calibration Verification Material (CVM): IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) contains one set of four vials. CVM1 contains 4.0 mL processed lyophilized human serum with preservatives after reconstitution. CVM2, CVM3 and CVM4 contain 2.0mL/vial of various levels of 3,31 Triiodo-L-Thyronine (Free Acid) in processed lyophilized human serum with preservatives after reconstitution.

IMMULITE® 2000 Gastrin Calibration Verification Material (CVM): The IMMULITE 2000 Gastrin Calibration Verification Material (CVM) contains one set of four vials, 2.0 mL each after reconstitution. CVM1 contains a lyophilized processed buffered human protein matrix with preservatives. CVM2, CVM3 and CVM4 contain various levels of synthetic-human gastrin in a lyophilized processed buffered human 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)

Non-Clinical Performance Testing:

Stability Summary:
IMMULITE® 2000 LH Calibration Verification Material (CVM): The IMMULITE® 2000 LH Calibration Verification Materials are stable up to 9 years when stored at 2-8°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after reconstitution.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM): The IMMULITE 2000 Free T3 Calibration Verification Materials are stable up to 1.5 years when stored at -20°C prior to reconstitution.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM): The IMMULITE 2000 Gastrin Calibration Verification Materials are stable up to 1.5 years when stored at ≤ -20°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after reconstitution.

Stability Protocol Summary:
CVM study protocols are run as part of the calibrator stability testing. Stability CVMs and reference CVMs are run in duplicate (as a minimum) at specified time points and the dose value is determined from the reference calibrator curve.
IMMULITE® 2000 LH Calibration Verification Material (CVM) time points: 0, 72, 84, 109 months. For Open Component testing, LH CVM lot 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) time points: 0, 6, 12, 18 months.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) time points: 0, 6, 12, 18 months. For Open Component testing, CVM 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions.

Stability Acceptance Criteria Summary:
IMMULITE® 2000 LH Calibration Verification Material (CVM): Requires dose value of stability calibrator/CVM to fall between ±18% of assigned dose for CVM level 2, ±12% for CVM level 3 and 14% for CVM level 4.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM): Requires dose value of stability calibrator/CVM to fall between ±25% of assigned dose for CVM level 2, ±10% for CVM level 3 and 15% for CVM level 4.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM): Requires dose value of stability calibrator/CVMs to fall between ±12% of assigned dose for CVM level 2, ±8% for CVM level 3 and 12% for CVM level 4.

Traceability:
IMMULITE® 2000 LH Calibration Verification Material (CVM): Traceable to WHO 1st IRP 68/40 and 2nd IS 80/552.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM): Traceable to an internal material which has been gravimetrically prepared.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM): Traceable to Medical Research Council Research Standard A for gastrin II, porcine (NIBSC 66/138).

Value Assignment:
All CVMs are 4 level materials, a subset of 6-13 level calibrators used internally. Value assigned using assigned reference calibrators.
IMMULITE® 2000 LH Calibration Verification Material (CVM): 6 levels of commercially available controls and 5 normal and 25 patient samples were used to validate calibrator/CVM value assignments. Tested on 27 replicates (9 runs, 3 replicates/run) across 7 IMMULITE 2000 systems and 4 reagent kit lots.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM): 6 levels of commercially available controls and 30 normal patient samples were used to validate calibrator/CVM value assignments. Tested on 15 replicates (5 runs, 3 replicates/run) across 4 IMMULITE 2000 systems and 3 reagent kit lots.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM): 4 levels of commercially available controls and 49 spiked serum samples and 5 normal serum samples were used to validate calibrator/CVM value assignments. Tested on 27 replicates (9 runs, 3 replicates/run) across 9 IMMULITE 2000 systems and 3 reagent kit lots.

Expected Values/Reference Range:
Ranges established based on Target Mean and ± 2 Standard Deviation (SD).
IMMULITE® 2000 LH Calibration Verification Material (CVM): Tested on 27 replicates (9 runs, 3 replicates/run) across 7 IMMULITE 2000 systems and 4 reagent kit lots. Expected assay range up to 200 mIU/mL.
IMMULITE® 2000 Free T3 Calibration Verification Material (CVM): Tested on 15 replicates (5 runs, 3 replicates/run) across 4 IMMULITE 2000 systems and 3 reagent kit lots. Expected assay range 1.0 to 40 pg/mL.
IMMULITE® 2000 Gastrin Calibration Verification Material (CVM): Tested on 27 replicates (9 runs, 3 replicates/run) across 9 IMMULITE 2000 systems and 3 reagent kit lots. Expected assay range up to 1000 pg/mL.

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

Not Found

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.

K140258, 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

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 29, 2014

SIEMENS HEALTHCARE DIAGNOSTICS INC. ASHA GARTLAND TECHNICAL REGULATORY AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591

Re: K142811

Trade/Device Name: Immulite® 2000 LH Calibration Verification Material (CVM), Immulite® 2000 Free T3 Calibration Verification Material (CVM), Immulite® 2000 Gastrin Calibration Verification Material (CVM) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJX Dated: September 26, 2014 Received: September 29, 2014

Dear Ms. Asha Gartland:

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

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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Courtney

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K142811

Device Name

IMMULITE® 2000 LH Calibration Verification Material (CVM) IMMULITE® 2000 Free T3 Calibration Verification Material (CVM) IMMULITE® 2000 Gastrin Calibration Verification Material (CVM)

Indications for Use (Describe)

The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems.

The IMMULITE® 2000 Free T3 Calbration Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Free T3 assay on the IMMULITE 2000 systems

The IMMULITE® 2000 Gastrin Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE Gastrin assay on the IMMULITE 2000 systems

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: K142811

1. Submitter 511 Benedict Avenue Mailing Address: Tarrytown, NY 10591
  Contact Person:
Phone Number: Fax Number: E-mail Address: Date Prepared:
1. Device Name Proprietary Name: Measurand:

Type of Test:

Regulation Section: Classification: Products Code: Panel:

Predicate Device Name

Predicate 510(k) No:

Device Description:

Siemens Healthcare Diagnostics Inc.

Asha Gartland Technical Regulatory Affairs Specialist (914)-524-3257 (914)-524-2101 asha.gartland@siemens.com October 28th 2014

IMMULITE® 2000 LH Calibration Verification Material Quality Control materials for IMMULITE® 2000 LH assay Calibration Verification Material (CVM) for IMMULITE® 2000 LH assay

21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Clinical Chemistry (75)

IMMULITE® 2000 Intact PTH Calibration Verification Material (CVM) K140258

Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented.

1. Intended Use: Indication for Use:
  Special Conditions for Use Statement(s): Special Instrument Requirements:
1. Technological Characteristics and Substantial Equivalence Comparison with Predicate:
  See Indications for Use Statement below: The IMMULITE® 2000 LH Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE LH assay on the IMMULITE 2000 systems.

For prescription use only

IMMULITE® 2000 Systems

A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® 2000 LH 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 LH CVM	Predicate Device
IMMULITE 2000 Intact PTH CVM
Intended
Use	The IMMULITE® 2000 LH
Calibration Verification Material
(CVM) is for in vitro diagnostic use in
the verification of calibration of the
IMMULITE LH 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.
Form	Lyophilized	Same
Stability	Stable unopened until the expiration
date	Same
Levels	4	Same
Use	Single Use Only	Same

	DIFFERENCES
	Candidate Device
IMMULITE 2000 LH CVM	Predicate Device
IMMULITE 2000 Intact PTH
CVM
Analyte	LH	Intact PTH
Storage	2 -8 °C	≤-20°C
Matrix	Bovine serum with preservatives	Buffered bovine protein 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 real-time shelf life and open component (in-use or open vial) claim for the IMMULITE 2000 LH 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 reconstitution.

The IMMULITE® 2000 LH Calibration Verification Materials are stable up to 9 years when stored at 2-8°C prior to opening and 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
LLHCVM1	72	84	109
LLHCVM2	72	84	109
LLHCVM3	72	84	109
LLHCVM4	72	84	109

Table 2: Stability Time Points

For Open Component testing, the results are determined from a 2-point adjustment. Using IMMULITE 2000 LH (L2KLH2) kit lot 305, LH CVM lot 090 was tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (15-25°C) conditions and compared to the determinations at time zero.

7.1.2 Stability Acceptance Criteria Summary:

The Acceptance Criteria for the IMMULITE LH criteria requires dose value of stability calibrator/CVM to fall between ±18% of assigned dose for CVM level 2, ±12% for CVM level 3 and 14% for CVM level 4.

.The acceptance criterion is summarized in Table 3.

CVM level	Assigned Dose (mIU/mL)	Guideline Criteria % difference to assigned dose	Acceptable dose range (mIU/mL)
LLHCVM1	0.00	Not Applicable	≤ 0.1
LLHCVM2	1.28	±18%	1.05 - 1.51
LLHCVM3	47.2	±12%	41.5 – 52.9
LLHCVM4	190	±14%	163 – 217

Table 3 Acceptance criteria for stability of IMMULITE 2000 LH CVM

7.2 Traceability:

The IMMULITE LH is traceable to WHO 1st IRP 68/40 and 2nd IS 80/552. The CVMs are manufactured using qualified materials and measurement procedures.

7.3 Value Assignment:

IMMULITE 2000 LH CVMs are 4 level materials which are a subset of 13 level LH calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of LH 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 LH antigen stock and are traceable to WHO 1st IRP 68/40 and 2nd IS 80/552. Six levels of commercially available controls and 5 normal and 25 patient samples were used to validate calibrator/CVM value assignments.

The CVMs are manufactured using qualified materials and measurement procedures. The IMMULITE LH calibrators/CVMs were tested on 27 replicates in total, comprised of 9 runs, 3 replicates per run, 7 IMMULITE 2000 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 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, 7 IMMULITE 2000 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 up to 200 mIU/mL. The target values in Table 4 can be considered as guidelines.

| Analyte
target levels | CVM Level | *Target
Mean
( mIU/mL) | Standard
Deviation
(SD) | Guideline ±2SD Range
( mIU/mL ) | |
|--------------------------|------------------|------------------------------|-------------------------------|------------------------------------|------|
| | LLHCVM1 | 0.00 | - | 0.00 | ≤0.1 |
| | LLHCVM2 | 1.71 | 0.155 | 1.40 | 2.02 |
| | LLHCVM3 | 51.5 | 3.1 | 45.3 | 57.7 |
| | LLHCVM4 | 202 | 14.0 | 174 | 230 |
| Assay Range | Up to 200 mIU/mL | | | | |

Table 4: Target Values

*Note: when CVMs are run by the customer, an actual value below and above the assay range will result when the customer programs the CVMs as calibration verifiers in the instrument software. If programmed as a patient or control, then the software will give values as the assay lower and upper 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.

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 LH 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 Intact PTH 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 LH 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: K142811

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:	October 28th, 2014
2. Device Name
Proprietary Name:	IMMULITE® 2000 Free T3 Calibration Verification Material
Measurand:	Quality Control material for IMMULITE® 2000 Free T3 assay
Type of Test:	Calibration Verification Material (CVM) for IMMULITE® 2000
Free T3 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
Predicate 510(k) No:	IMMULITE® 2000 HCG Calibration Verification Material (CVM)
K133128
4. Device Description:	IMMULITE® 2000 Free T3 Calibration Verification Material (CVM)
contains one set of four vials. CVM1 contains 4.0 mL processed
lyophilized human serum with preservatives after reconstitution.
CVM2, CVM3 and CVM4 contain 2.0mL/vial of various levels of
3,31 Triiodo-L-Thyronine (Free Acid) in processed lyophilized
human serum with preservatives after reconstitution.
5. Intended Use:
Indication for Use:	See Indications for Use Statement below
The IMMULITE® 2000 Free T3 Calibration Verification Material
(CVM) is for in vitro diagnostic use in the verification of calibration
of the IMMULITE Free T3 assay on the IMMULITE 2000 systems.
Special Conditions for
Use Statement(s):	For prescription use only
Special Instrument
Requirements:	IMMULITE® 2000 Systems
6. Technological
Characteristics and
Substantial Equivalence
Comparison with Predicate:	A comparison of the device features, intended use, and other
information demonstrates that the IMMULITE® Free T3 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
Free T3 CVM	Predicate Device
IMMULITE 2000 HCG CVM
Intended
Use	The IMMULITE® 2000 Free T3
Calibration Verification Material (CVM) is
for in vitro diagnostic use in the verification
of calibration of the IMMULITE Free T3
assay on the IMMULITE 2000 systems	The IMMULITE® HCG
Calibration Verification Material
(CVM) is for in vitro diagnostic use
in the verification of calibration of
the IMMULITE HCG assay on the
IMMULITE 2000 systems
Storage	≤-20°C	Same
Stability	Stable unopened until the expiration date	Same
Levels	4	Same
Use	Single Use Only	Same
Matrix	Human serum with preservatives	Same

DIFFERENCES
	Candidate Device
Free T3 CVM	Predicate Device
IMMULITE 2000 HCG CVM
Analyte	Free T3	HCG
Form	Lyophilized	Liquid

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 shelf life claim for the IMMULITE 2000 Free T3 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 reconstitution.

The IMMULITE 2000 Free T3 Calibration Verification Materials are stable up to 1.5 years when stored at -20°C prior to reconstitution.

7.1.1 Stability Protocol Summary:

CVM Level
LFT3CVM1	6	12	18
LFT3CVM2	6	12	18
LFT3CVM3	6	12	18
LFT3CVM4	6	12	18

Table 2: Stability Time Points

7.1.2 Stability Acceptance Criteria Summary:

The Acceptance Criteria for the IMMULITE Free T3 criteria requires dose value of stability calibrator/CVM to fall between ±25% of assigned dose for CVM level 2, ±10% for CVM level 3 and 15% for CVM level 4.

The acceptance criterion is summarized in Table 3.

Table 3 Acceptance criteria for stability of IMMULITE 2000 Free T3 CVM

| CVM level | Assigned
Dose
(pg/dL) | Guideline
Criteria
% difference to
assigned dose | Acceptable
dose range
(pg/dL) |
|-----------|-----------------------------|-----------------------------------------------------------|-------------------------------------|
| LFT3CVM1 | 0.00 | N/A | ≤ 1.00 |
| LFT3CVM2 | 1.48 | ±25% | 1.11 – 1.85 |
| LFT3CVM3 | 7.30 | ±10% | 6.57 – 8.03 |
| LFT3CVM4 | 44.5 | ±15% | 37.8 – 51.2 |

7.2 Traceability:

The IMMULITE 2000 Free T3 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:

The IMMULITE 2000 Free T3 CVMs are 4 level materials which are a subset of 6 level Free T3 calibrators. Calibrators are not commercialized but are used internally during manufacture and release testing of Free T3 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 Free T3 antigen stock and are traceable to an internal material which has been gravimetrically prepared. Six levels of commercially available controls and 30 normal patient samples were used to validate calibrator/CVM value assignments.

The calibrators/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, 4 IMMULITE 2000 systems and 3 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 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.

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7.4 Expected Values/Reference Range:

Each CVM level was on 15 replicates in total, comprised of 5 runs, 3 replicates per run, 4 IMMULITE 2000 systems and 3 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 Free T3 CVM Calibration Verification Material lot-specific package insert. *

The expected assay range is 1.0 to 40 pg/mL. The target values in Table 4 can be considered as guidelines.

| Analyte
target levels | CVM Level | *Target
Mean
(pg/mL) | Standard
Deviation
(SD) | Guideline ±2SD Range
(pg/mL) |
|--------------------------|-------------------------------|-----------------------------|-------------------------------|---------------------------------|
| | LF3CVM1 | 0.00 | - | ≤1.00 |
| | LF3CVM2 | 1.48 | 0.185 | 1.85 |
| | LF3CVM3 | 7.30 | 0.5475 | 8.40 |
| | LF3CVM4 | 44.5 | - | - |
| | *90% LF3CVM4 +
10% LF3CVM1 | 40.1 | 3.00 | 46.1 |
| Assay Range | 1.0 to 40 pg/mL | | | |

Table 4: Target Values

Note:

CVM4 requires dilution to ensure that the target value is within +10% of the top of the reportable range of the assay.

** When CVMs are run by the customer, an actual value below and above the assay range will result when the customer programs the CVMs as calibration verifiers in the instrument software. If programmed as a patient or control, then the software will give values as the assay lower and upper range.

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 Free T3 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 HCG 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 Free T3 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
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:	October 28th, 2014
2. Device Name
Proprietary Name:	IMMULITE® 2000 Gastrin Calibration Verification Material
Measurand:	Quality Control materials for IMMULITE® 2000 Gastrin assay
Type of Test:	Calibration Verification Material (CVM) for IMMULITE® 2000
Gastrin 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 DHEA-SO4 Calibration Verification Material
(CVM)
Predicate 510(k) No:	K140258
4. Device Description:	The IMMULITE 2000 Gastrin Calibration Verification Material
(CVM) contains one set of four vials, 2.0 mL each after
reconstitution. CVM1 contains a lyophilized processed buffered
human protein matrix with preservatives. CVM2, CVM3 and
CVM4 contain various levels of synthetic-human gastrin in a
lyophilized processed buffered human protein matrix with
preservatives.
5. Intended Use:	See Indications for Use Statement below
Indication for Use:	The IMMULITE® 2000 Gastrin Calibration Verification Material
(CVM) is for in vitro diagnostic use in the verification of
calibration of the IMMULITE Gastrin assay on the IMMULITE
2000 systems
Special Conditions for
Use Statement(s):
Special Instrument
Requirements:	For prescription use only
IMMULITE® 2000 Systems
6. Technological Characteristics
and Substantial Equivalence
Comparison with Predicate:	A comparison of the device features, intended use, and other
information demonstrates that the IMMULITE® 2000 Gastrin
Calibration Verification Material (CVM) is substantially equivalent
to the predicate device as summarized in Table 1.

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

| | IMMULITE Gastrin assay on the
IMMULITE 2000 systems | IMMULITE DHEA-SO4 assay on the
IMMULITE 2000 systems |
|-------------|--------------------------------------------------------|---------------------------------------------------------|
| Form | Lyophilized | Same |
| Levels | 4 | Same |
| Stability | Stable unopened until the expiration date | Same |
| Storage | ≤-20°C | Same |
| Use | Single Use Only | Same |
| DIFFERENCES | | |

DIFFERENCES
	Candidate Device
IMMULITE 2000 Gastrin CVM	Predicate Device
IMMULITE 2000 DHEA-SO4 CVM
Analyte	Gastrin	DHEA-SO4
Matrix	Buffered human protein with
preservatives	Human serum with preservatives

Table 1: Substantial Equivalence Comparison

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 real-time shelf life and open component (in-use or open vial) claim for the IMMULITE 2000 Gastrin 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 reconstitution.

The IMMULITE 2000 Gastrin Calibration Verification Materials are stable up to 1.5 years when stored at ≤ -20°C prior to opening and for 8 hours at ambient or room temperature (15-25°C) after reconstitution.

7.1.1 Stability Protocol Summary:

CVM Level
LGACVM1	6	12	18
LGACVM2	6	12	18
LGACVM3	6	12	18
LGACVM4	6	12	18

Table 2: Stability Time Points

For Open Component testing, the results are determined from a 2-point adjustment. Using IMMULITE 2000 Gastrin kit (L2KGA2) lot 229, CVM 090 was 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 IMMULITE 2000 Gastrin criteria requires dose value of stability calibrator/CVMs to fall between ±12% of assigned dose for CVM level 2, ±8% for CVM level 3 and 12% for CVM level 4.

The acceptance criterion is summarized in Table 3.

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| CVM level | Assigned Dose
(pg/mL) | Guideline Criteria
% difference to
assigned dose | Acceptable dose
range (pg/mL) |
|-----------|--------------------------|--------------------------------------------------------|----------------------------------|
| LGACVM1 | 0.00 | N/A | the assay lower and upper range

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 Gastrin 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 DHEA-SO4 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 Gastrin Calibration Verification Material does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.