(82 days)
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.
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.
The provided document describes two devices: the IMMULITE® IGF Control Module and the IMMULITE® Gastrin Control Module. Both are quality control materials, and the studies performed focus on their stability and value assignment rather than typical diagnostic performance metrics (like sensitivity, specificity, or reader studies).
Here's an analysis based on the provided text:
IMMULITE® IGF Control Module
1. Table of Acceptance Criteria and Reported Device Performance (Stability)
| Level | Range (Acceptance Criteria) | +/-% Acceptance Criteria | Reported Performance (Implied from "meets the performance specifications") |
|---|---|---|---|
| IMMULITE 2000 IGF-I (ng/mL) | |||
| LGCOC10023 | 65 – 97 | 20 | Met |
| LGCOC20023 | 194 - 290 | 20 | Met |
| IMMULITE 2000 IGFBP-3 (µg/mL) (kit lots 210 and below) | |||
| LGCOC10023 | 0.84 - 1.20 | 17.6 | Met |
| LGCOC20023 | 3.5 - 4.9 | 16.7 | Met |
| IMMULITE 2000 IGFBP-3 (µg/mL) (kit lots 211 and above) | |||
| LGCOC10023 | 0.80 - 1.16 | 18.4 | Met |
| LGCOC20023 | 3.24 - 4.60 | 17.3 | Met |
| Open Vial Stability | N/A (difference between fresh and stored vial) | ±10% | Met |
Study Details:
-
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" for stability refers to samples of the IMMULITE® IGF Control Module (specifically lot 23 for shelf-life, and lot 024 for open-vial).
- Quantity: "Stability controls are run in duplicate (as a minimum)" at specified time points (1 day, 6, 12, 18, 24, 30, and 36 months). For open vial, a freshly opened vial was compared to one opened 35 days prior.
- Data Provenance: The study was conducted by Siemens Healthcare Diagnostics Inc. and is non-clinical, likely internal testing. No specific country of origin or retrospective/prospective nature (beyond the real-time stability) is mentioned.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material; its "truth" is its inherent stability and value according to its manufacturing specifications, not a diagnostic finding requiring expert interpretation.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Data points for stability are quantitative measurements, not subjective evaluations requiring adjudication.
-
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a quality control material and not an AI-powered diagnostic tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical control material, not an algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For stability, the ground truth is the expected performance of the control material over time when stored under specified conditions, defined by the manufacturer's internal specifications and verified through testing against these predefined ranges.
- For Value Assignment, the controls are value assigned using assigned reference controls. These reference controls are prepared using IGF-I and IGFBP-3 antigen stock, and the controls are manufactured using qualified materials and measurement procedures.
-
8. The sample size for the training set:
- Value Assignment "Training": For value assignment, "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." This serves as the data for establishing the expected values.
- Stability: This concept doesn't directly apply as stability is validated over time against defined criteria, not "trained."
-
9. How the ground truth for the training set was established:
- Value Assignment: The ground truth (assigned values for the controls) is established by running the controls (minimum 10 replicates) and reference controls (2 replicates) together in each assay, using an adjusted curve. The control values are calculated based on recovered values from each instrument independently and then averaged across all systems. Validation is performed by checking the recovery of patient samples and reference controls against their target ranges.
IMMULITE® Gastrin Control Module
1. Table of Acceptance Criteria and Reported Device Performance (Stability)
| Control Level | Range (Acceptance Criteria) | +/-% Acceptance Criteria | Reported Performance (Implied from "meets the performance specifications") |
|---|---|---|---|
| LGAC10030 | 85 - 113 | 14.0% | Met |
| LGAC20030 | 341 - 453 | 14.2% | Met |
| Open Vial Stability | N/A (difference between stored and fresh vial) | ±10% | Met |
Study Details:
-
2. Sample size used for the test set and the data provenance:
- Test Set Description: The "test set" for stability refers to samples of the IMMULITE® Gastrin Control Module (specifically lot 30 for shelf-life, and lot 030 for open-vial).
- Quantity: "Stability controls are run in duplicate (as a minimum)" at specified time points (1 day, 6, 12, 18, 24, 30, and 36 months). For open vial, a freshly opened vial was compared to one opened 35 days prior.
- Data Provenance: The study was conducted by Siemens Healthcare Diagnostics Inc. and is non-clinical, likely internal testing. No specific country of origin or retrospective/prospective nature (beyond the real-time stability) is mentioned.
-
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material; its "truth" is its inherent stability and value according to its manufacturing specifications, not a diagnostic finding requiring expert interpretation.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Data points for stability are quantitative measurements, not subjective evaluations requiring adjudication.
-
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a quality control material and not an AI-powered diagnostic tool.
-
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical control material, not an algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For stability, the ground truth is the expected performance of the control material over time when stored under specified conditions, defined by the manufacturer's internal specifications and verified through testing against these predefined ranges.
- For Value Assignment, the controls are value assigned using assigned reference controls. These reference controls are prepared using qualified Gastrin antigen stock, and the controls are manufactured using qualified materials and measurement procedures.
-
8. The sample size for the training set:
- Value Assignment "Training": For value assignment, "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." This serves as the data for establishing the expected values.
- Stability: This concept doesn't directly apply as stability is validated over time against defined criteria, not "trained."
-
9. How the ground truth for the training set was established:
- Value Assignment: The ground truth (assigned values for the controls) is established by running the controls (minimum 10 replicates) and reference controls (2 replicates) together on an adjusted curve. The control values are assigned based on the recovered values for each run on each instrument independently and then averaged across all systems. Data is reviewed for outliers, bi-modality or skewness. Validation is performed by checking the recovery of patient samples and reference controls against their target ranges.
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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
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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
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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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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 | |
| IntendedUse | IMMULITE IGF Control Module is anassayed, bi-level control intended foruse with IMMULITE/IMMULITE 1000and IMMULITE 2000 IGF-I, andIMMULITE/IMMULITE 1000 andIMMULITE 2000 IGFBP-3 assays. It isintended as an aid in monitoring day-to-day assay performance. | SHBG Controls are assayed, bi-levelcontrols intended for use with theIMMULITE 2000 SHBG assay. Theyare intended as an aid in monitoringday-to-day assay performance. |
| Form | Lyophilized | Same |
| Stability | Stable unopened until the expirationdate | Same |
| Levels | 2 | Same |
| Matrix | Bovine protein/buffer matrix withpreservatives | 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 afterreconstitution or at -20°C for 6months (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.
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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 ControlModule 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.
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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
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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
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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.
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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: 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
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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 DeviceIMMULITE® Gastrin ControlModule | Predicate DeviceIMMULITE® SHBG Controls | |
| Intended Use | The IMMULITE GastrinControl Module is anassayed, bi-level controlintended for use with theIMMULITE/IMMULITE 1000 andIMMULITE 2000 Gastrin assay.It is intended as an aid in monitoringday-to-day assay performance. | SHBG Controls are assayed, bi-levelcontrols intended for use with theIMMULITE 2000 SHBG assay.They are intended as an aid inmonitoring day-to-day assayperformance. |
| Form | Lyophilized | Same |
| Levels | 2 | Same |
| Stability | Stable unopened until the expirationdate | Same |
| DIFFERENCES | ||
|---|---|---|
| Candidate DeviceIMMULITE® GastrinControl Module | Predicate DeviceIMMULITE® SHBG Controls | |
| Analyte | Gastrin | SHBG |
| Matrix | Buffered matrix | Non-human (bovine) protein/buffermatrix |
| Storage | -20°C for 30 days after reconstitution(aliquotted) | 2 -8°C for 30 days after reconstitution orat -20°C for 6 months (aliquotted) |
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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
| GastrinControl 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.
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| 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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§ 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.