(82 days)
Not Found
No
The document describes assayed control materials for laboratory assays, which are used for quality control and monitoring assay performance. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a control module for in-vitro diagnostic assays, used to monitor day-to-day assay performance, not to directly treat a patient.
No
Explanation: The device is described as a control module intended for monitoring day-to-day assay performance, not for diagnosing medical conditions in patients. It is used for quality control purposes, as explicitly stated in the 'Summary of Performance Studies'.
No
The device description explicitly states that the device contains lyophilized substances in vials, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use with IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays" and "intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay." These assays are used to measure substances in biological samples (in vitro).
- Purpose: The intended use also states it is "intended as an aid in monitoring day-to-day assay performance." This indicates its use in the quality control of diagnostic tests performed outside the body.
- Device Description: The device contains lyophilized substances in a buffer matrix, which are typical components of controls used in in vitro diagnostic assays.
- Performance Studies: The performance studies describe testing related to stability and value assignment, which are standard evaluations for IVD controls.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K955440; IMMULITE® SHBG Controls) strongly suggests that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IMMULITE® IGF Control Module is an assayed, bi-level control intended for use with IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-to-day assay performance.
IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
IMMULITE® IGF Control Module contains one set of 2 vials, each 4.0mL after reconstitution, containing lyophilized IGF-I and IGFBP-3 in a protein buffer matrix.
IMMULITE Gastrin Control Module contains one set of 2 vials, each 2.0mL after reconstitution, containing lyophilized synthetic-human G-17 gastrin in a buffer matrix.
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 IGF Control Module): The stability study was conducted to validate real-time shelf life and open vial claim for the IMMULITE IGF Control Module to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the control material before and after reconstitution.
The IMMULITE IGF Control Module is stable for up to 3 years from date of manufacture, when stored at 2 - 8 °C prior to opening. Stability, after opening and reconstitution, is for 30 days at -20℃, if aliquotted and frozen immediately.
Stability Protocol Summary: The stability controls are run in duplicate (as a minimum) and the dose value determined from a 2point adjustment at the time points as shown in Table 2. Stability controls are run every 6 months until expiry.
For open vial testing, the results are determined from a 2-point adjustment. Using IGF Control Lot 024 a freshly opened vial was compared to a vial opened 35 days prior and stored at -20°C.
Stability Acceptance Criteria Summary: The Acceptance Criteria for the IMMULITE IGF Control Module stability is summarized in Table 3.
For open vial stability testing, the difference between the freshly opened vial dose value should be within ±10%.
Non-Clinical Performance Testing
Stability Summary (IMMULITE Gastrin Control Module): The stability study was conducted to validate real-time shelf life and open vial claim for the IMMULITE Gastrin Control Module to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the control material before and after reconstitution.
The IMMULITE Gastrin Control Module is stable for up to 3 years from date of manufacture, when stored at 2 - 8 ℃ prior to opening. Stability after opening and reconstitution, is for 30 days at -20℃, if aliquotted and frozen immediately.
Stability Protocol Summary: The stability controls are run in duplicate (as a minimum) and the dose value determined from a 2point adjustment at the time points as shown in Table 2. Stability controls are run every 6 months until expiry.
For Open Vial testing, the results are determined from a 2-point adjustment. Using Gastrin Control Lot 030 a freshly opened vial was compared to a vial opened 35 days prior and stored at -20℃.
Stability Acceptance Criteria Summary: The Acceptance Criteria for the IMMULITE Gastrin Control Module is summarized in Table 3.
For Open Vial stability testing the difference between the stored and the freshly opened vial dose value should be within ±10%.
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.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS ASHA GARTLAND TECHNICAL REGULATORY AFFAIRS SPECIALIST 511 BENEDICT AVENUE TARRYTOWN NY 10591
April 14, 2015
Re: K150132
Trade/Device Name: IMMULITE® IGF Control Module IMMULITE® Gastrin Control Module Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: January 19, 2015 Received: January 21, 2015
Dear Asha Gartland:
This letter corrects our substantially equivalent letter of April 13, 2015.
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. Isting 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
1
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/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 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.
Katherine Serrano -S
For : 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
2
Indications for Use
510(k) Number (if known) K150132
Device Name IMMULITE® IGF Control Module IMMULITE® Gastrin Control Module
Indications for Use (Describe)
IMMULITE® IGF Control Module is an assayed, bi-level control intended for use with IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-to-day assay performance.
IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D)
ロOver-The-Counter Use (21 CFR 801 Subpart C)
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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 equivalence.
The assigned 510(k) Number: K150132
-
- Submitter Mailing Address:
Contact Person:
- Submitter Mailing Address:
Phone Number: Fax Number: E-mail Address: Date Prepared:
-
- Device Name Proprietary Name:
Regulation Section: Classification: Products Code: Panel:
- Device Name Proprietary Name:
-
- Predicate Device Name Predicate 510(k) No:
4. Device Description:
-
- Intended Use: Indication for Use:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591
- Intended Use: Indication for Use:
Asha Gartland Technical Regulatory Affairs Specialist (914)-524-3257 (914)-524-2101 asha.gartland@siemens.com March 2nd, 2015
IMMULITE® IGF Control Module
21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed) Clinical Chemistry (75)
IMMULITE® SHBG Controls K955440
IMMULITE® IGF Control Module contains one set of 2 vials, each 4.0mL after reconstitution, containing lyophilized IGF-I and IGFBP-3 in a protein buffer matrix.
See Indications for Use Statement below: IMMULITE® IGF Control Module is an assayed, bi-level control intended for use with IMMULITE/IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE/IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-today assay performance.
Special Conditions for Use Statement(s):
For prescription use only
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Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a teal, sans-serif font. The letters are bold and evenly spaced. The background is plain white, which makes the text stand out.
Special Instrument Requirements:
-
- Technological Characteristics and Substantial Equivalence Comparison with Predicate:
IMMULITE® 1000 and 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® IGF Control Module is substantially equivalent to the predicate device as summarized in Table 1.
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| Table 1: Substantial Equivalence Comparison | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| IMMULITE IGF Control Module | IMMULITE SHBG Controls | |
| Intended | ||
| Use | IMMULITE IGF Control Module is an | |
| assayed, bi-level control intended for | ||
| use with IMMULITE/IMMULITE 1000 | ||
| and IMMULITE 2000 IGF-I, and | ||
| IMMULITE/IMMULITE 1000 and | ||
| IMMULITE 2000 IGFBP-3 assays. It is | ||
| intended as an aid in monitoring day-to- | ||
| day assay performance. | SHBG Controls are assayed, bi-level | |
| controls intended for use with the | ||
| IMMULITE 2000 SHBG assay. They | ||
| are intended as an aid in monitoring | ||
| day-to-day assay performance. | ||
| Form | Lyophilized | Same |
| Stability | Stable unopened until the expiration | |
| date | Same | |
| Levels | 2 | Same |
| Matrix | Bovine protein/buffer matrix with | |
| preservatives | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | Predicate Device | |
| IMMULITE IGF Control Module | IMMULITE SHBG Controls | |
| Analyte(s) | IGF-I and IGFBP-3 | SHBG |
| Storage | -20°C for 30 days after reconstitution | |
| (aliquotted) | 2 -8 °C for 30 days after | |
| reconstitution or at -20°C for 6 | ||
| months (aliquotted) |
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.
6
7.1 Stability Summary:
The stability study was conducted to validate real-time shelf life and open vial claim for the IMMULITE IGF Control Module to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the control material before and after reconstitution.
The IMMULITE IGF Control Module is stable for up to 3 years from date of manufacture, when stored at 2 - 8 °C prior to opening. Stability, after opening and reconstitution, is for 30 days at -20℃, if aliquotted and frozen immediately.
7.1.1 Stability Protocol Summary:
The stability controls are run in duplicate (as a minimum) and the dose value determined from a 2point adjustment at the time points as shown in Table 2. Stability controls are run every 6 months until expiry.
| IGF Control
| Module level | Time-Points in Days (months) | ||||||
|---|---|---|---|---|---|---|---|
| IGF-I | |||||||
| LGCOC1 | 1 | 182 | |||||
| (6 months) | 365 | ||||||
| (12 Months) | 548 | ||||||
| (18 months) | 730 | ||||||
| (24 months) | 912 | ||||||
| (30 months) | 1095 | ||||||
| (36 months) | |||||||
| LGCOC2 | 1 | 182 | |||||
| (6 months) | 365 | ||||||
| (12 Months) | 548 | ||||||
| (18 months) | 730 | ||||||
| (24 months) | 912 | ||||||
| (30 months) | 1095 | ||||||
| (36 months) | |||||||
| IGFBP-3 | |||||||
| LGCOC1 | 1 | 182 | |||||
| (6 months) | 365 | ||||||
| (12 Months) | 548 | ||||||
| (18 months) | 730 | ||||||
| (24 months) | 912 | ||||||
| (30 months) | 1095 | ||||||
| (36 months) | |||||||
| LGCOC2 | 1 | 182 | |||||
| (6 months) | 365 | ||||||
| (12 Months) | 548 | ||||||
| (18 months) | 730 | ||||||
| (24 months) | 912 | ||||||
| (30 months) | 1095 | ||||||
| (36 months) |
Table 2: Stability Time Points
For open vial testing, the results are determined from a 2-point adjustment. Using IGF Control Lot 024 a freshly opened vial was compared to a vial opened 35 days prior and stored at -20°C.
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE IGF Control Module stability is summarized in Table 3.
7
Table 3 Acceptance criteria for stability of IMMULITE IGF Control lot 23
| Level | Range | +/-% Acceptance Criteria |
|---|---|---|
| IMMULITE 2000 IGF-I (ng/mL) | ||
| LGCOC10023 | 65 – 97 | 20 |
| LGCOC20023 | 194 - 290 | 20 |
| IMMULITE 2000 IGFBP-3 (µg/mL) | ||
| kit lots 210 and below | ||
| LGCOC10023 | 0.84 - 1.20 | 17.6 |
| LGCOC20023 | 3.5 - 4.9 | 16.7 |
| IMMULITE 2000 IGFBP-3 (µg/mL) | ||
| kit lots 211 and above | ||
| LGCOC10023 | 0.80 - 1.16 | 18.4 |
| LGCOC20023 | 3.24 - 4.60 | 17.3 |
For open vial stability testing, the difference between the freshly opened vial dose value should be within ±10%.
7.2 Traceability:
The controls are used for quality control purposes only. Therefore traceability is not applicable for controls.
The IMMULITE controls are value assigned using assigned reference controls. The assigned reference controls are prepared using IGF-I and IGFBP-3 antigen stock. Human Recombinant IGF-I antigen and IGF-I/IGFBP-3 positive human serum are used.
7.3 Value Assignment:
The IMMULITE controls are value assigned using assigned reference controls. The assigned reference controls are prepared using IGF-I and IGFBP-3 antigen stock. The controls are manufactured using qualified materials and measurement procedures.
IGF controls are required to have a minimum of 100 control points from at least 3 kit lots and 3 instruments on both IMMULITE 1000 and IMMULITE 2000 platforms and for both IGF-I and IGFBP-3. Both the controls being targeted (minimum 10 replicates) and the reference controls (2 replicates) are run together in each assay. Each assay is run using an adjusted curve. The control values are calculated based on the recovered values for each instrument independently. Control values are then averaged across all systems. Validation of the value
8
assignment (quality control) is performed by calculating the recovery of patient samples and reference controls using the assigned control values. The reference controls must fall within their target ranges.
7.4 Expected Values
The controls must fall within their target ranges as shown in Table 4. Example of values from IGF control lot 0027.
| Control level | Mean | SD | 2SD Range |
|---|---|---|---|
| IMMULITE/IMMULITE 1000 IGF-I (ng/mL) kit lots 401 and above | |||
| LGCOC10027 | 91 | 9.1 | 73 - 109 |
| LGCOC20027 | 277 | 27.7 | 222 - 332 |
| IMMULITE 2000 IGF-I (ng/mL) kit lots 510-517 | |||
| LGCOC10027 | 75 | 7.5 | 60 - 90 |
| LGCOC20027 | 239 | 23.9 | 191 - 287 |
| IMMULITE 2000 IGF-I (ng/mL) kit lots 518 and above | |||
| LGCOC10027 | 70 | 7.0 | 56 - 84 |
| LGCOC20027 | 227 | 22.7 | 182 - 272 |
| IMMULITE/IMMULITE 1000 IGFBP-3 (µg/mL) all kit lots | |||
| LGCOC10027 | 1.10 | 0.12 | 0.86 - 1.34 |
| LGCOC20027 | 4.4 | 0.40 | 3.6 – 5.2 |
| IMMULITE 2000 IGFBP-3 (µg/mL) all kit lots | |||
| LGCOC10027 | 0.98 | 0.09 | 0.80 - 1.16 |
| LGCOC20027 | 3.8 | 0.32 | 3.2 - 4.4 |
Table 4 Control Target Range (lot 0027)
Assay range: IMMULITE 2000 IGF-I : up to 1600 ng/mL IMMULITE 2000 IGFBP-3: up to 16 µg/mL
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
9
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 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
8.0 Conclusion:
The IMMULITE® IGF Control Module is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the FDA cleared IMMULITE® SHBG Controls. 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® IGF Control Module does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
10
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: K150132
- Submitter Mailing Address:
Contact Person:
Phone Number: Fax Number: E-mail Address: Date Prepared:
-
- Device Name Proprietary Name:
Regulation Section: Classification: Products Code:
- Device Name Proprietary Name:
Panel:
-
- Predicate Device Name Predicate 510(k) No:
-
- Device Description:
-
- Intended Use: Indication for Use:
Special Conditions for Use Statement(s): Special Instrument Requirements:
Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591
Asha Gartland Technical Regulatory Affairs Specialist (914)-524-3257 (914)-524-2101 asha.gartland@siemens.com March 2nd, 2015
IMMULITE® Gastrin Control Module
21 CFR 862.1660, Quality Control Material Class I Reserved JJX - Single (Specified) Analyte Controls (Assayed and Unassayed)
Clinical Chemistry (75)
IMMULITE® 2000 SHBG Controls K955440
IMMULITE Gastrin Control Module contains one set of 2 vials, each 2.0mL after reconstitution, containing lyophilized synthetic-human G-17 gastrin in a buffer matrix.
See Indications for Use Statement below The IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.
For prescription use only
IMMULITE® 1000 and IMMULITE® 2000 Systems
11
Image /page/11/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 background is white, which makes the text stand out.
6. Technological Characteristics and Substantial Equivalence
Comparison with Predicate:
A comparison of the device features, intended use, and other information demonstrates that the IMMULITE® Gastrin Control Module is substantially equivalent to the predicate device as summarized in Table 1.
Table 1: Substantial Equivalence Comparison
| SIMILARITIES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE® Gastrin Control | ||
| Module | Predicate Device | |
| IMMULITE® SHBG Controls | ||
| Intended Use | The IMMULITE Gastrin | |
| Control Module is an | ||
| assayed, bi-level control | ||
| intended for use with the | ||
| IMMULITE/IMMULITE 1000 and | ||
| IMMULITE 2000 Gastrin assay. | ||
| It is intended as an aid in monitoring | ||
| day-to-day assay performance. | SHBG Controls are assayed, bi-level | |
| controls intended for use with the | ||
| IMMULITE 2000 SHBG assay. | ||
| They are intended as an aid in | ||
| monitoring day-to-day assay | ||
| performance. | ||
| Form | Lyophilized | Same |
| Levels | 2 | Same |
| Stability | Stable unopened until the expiration | |
| date | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate Device | ||
| IMMULITE® Gastrin | ||
| Control Module | Predicate Device | |
| IMMULITE® SHBG Controls | ||
| Analyte | Gastrin | SHBG |
| Matrix | Buffered matrix | Non-human (bovine) protein/buffer |
| matrix | ||
| Storage | -20°C for 30 days after reconstitution | |
| (aliquotted) | 2 -8°C for 30 days after reconstitution or | |
| at -20°C for 6 months (aliquotted) |
12
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 vial claim for the IMMULITE Gastrin Control Module to ensure that it maintains optimal product performance on IMMULITE 2000 platforms throughout the established shelf life of the control material before and after reconstitution.
The IMMULITE Gastrin Control Module is stable for up to 3 years from date of manufacture, when stored at 2 - 8 ℃ prior to opening. Stability after opening and reconstitution, is for 30 days at -20℃, if aliquotted and frozen immediately.
7.1.1 Stability Protocol Summary:
The stability controls are run in duplicate (as a minimum) and the dose value determined from a 2point adjustment at the time points as shown in Table 2. Stability controls are run every 6 months until expiry.
Table 2: Stability Time Points
| Gastrin
| Control level | Time-Points in Days (months) | ||||||
|---|---|---|---|---|---|---|---|
| LGAC1 | 1 | 182 | |||||
| (6 months) | 365 | ||||||
| (12 Months) | 548 | ||||||
| (18 months) | 730 | ||||||
| (24 months) | 912 | ||||||
| (30 months) | 1095 | ||||||
| (36 months) | |||||||
| LGAC2 | 1 | 182 | |||||
| (6 months) | 365 | ||||||
| (12 Months) | 548 | ||||||
| (18 months) | 730 | ||||||
| (24 months) | 912 | ||||||
| (30 months) | 1095 | ||||||
| (36 months) |
For Open Vial testing, the results are determined from a 2-point adjustment. Using Gastrin Control Lot 030 a freshly opened vial was compared to a vial opened 35 days prior and stored at -20℃.
7.1.2 Stability Acceptance Criteria Summary:
The Acceptance Criteria for the IMMULITE Gastrin Control Module is summarized in Table 3.
13
| Table 3 Acceptance criteria for stability of IMMULITE Gastrin Control lot 30 | ||
|---|---|---|
| Control Level | Range | +/-% Acceptance Criteria |
|---|---|---|
| LGAC10030 | 85 - 113 | 14.0% |
| LGAC20030 | 341 - 453 | 14.2% |
For Open Vial stability testing the difference between the stored and the freshly opened vial dose value should be within ±10%.
7.2 Traceability:
The controls are used for quality control purposes only. Therefore traceability is not applicable for controls.
The IMMULITE controls are value assigned using assigned reference controls. The assigned reference controls are prepared using qualified Gastrin antigen stock. Synthetic gastrin antigen is used.
7.3 Value Assignment:
The IMMULITE controls are value assigned using assigned reference controls. The assigned reference controls are prepared using qualified Gastrin antigen stock. The controls are manufactured using qualified materials and measurement procedures.
Gastrin controls are required to have a minimum of 100 control points from at least 3 kit lots and 3 instruments on both IMMULITE/IMMULITE 1000 and IMMULITE 2000 platforms. Both the controls being targeted (minimum 10 replicates) and the reference controls (2 replicates) are run together using an adjusted curve. The control values are assigned based on the recovered values for each run on each instrument independently. Control values are then averaged across all systems. The data is then reviewed for outliers (>3SD) and bi-modality or skewness within individual assays. Validation of the value assignment (quality control) is performed by calculating the recovery of patient samples and reference controls using the assigned control values. The reference controls must fall within their target ranges
7.4 Expected Values
The controls must fall within their target ranges as shown in Table 3. Example of values from Gastrin control lot 0035.
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| Control Level | Mean | 2 SD Range | |||
|---|---|---|---|---|---|
| IMMULITE/IMMULITE 1000 Gastrin (pg/mL) | |||||
| LGAC10035 | 94 | 6.1 | 82 - 106 | ||
| LGAC20035 | 364 | 29 | 306 - 422 | ||
| IMMULITE 2000 Gastrin (pg/mL) | |||||
| LGAC10035 | 94 | 6.6 | 81 - 107 | ||
| LGAC20035 | 363 | ટર્ડ | 313 - 413 |
Table 3 Control Target Range (lot 0035)
IMMULITE 2000 Gastrin Assay Range = Up to 1,000 pg/mL
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 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® IMMULITE Gastrin Control Module is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the FDA cleared IMMULITE® SHBG Controls. 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 Gastrin Control Module does not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.
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