(19 days)
The IDS-iSYS IGF-I Calibration Verifier is a device intended for verification of calibration of the IDS-iSYS IGF-I Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
The IDS-iSYS IGF-I calibration verifer matrix is composed of a buffer solution containing bovine serum albumin with sodium azide as a preservative. The IGF-I peptide is added to this matrix and the resulting solution is lyophilised.
Here's a summary of the acceptance criteria and study details for the IDS-iSYS IGF-I Calibration Verifier, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IDS-iSYS IGF-I Calibration Verifier are broadly defined by its intended use for calibration verification and its performance characteristics in value assignment and stability. While explicit numerical acceptance criteria for value assignment (e.g., a specific percentage deviation from the target) are not directly stated as pass/fail thresholds, the methodology for establishing the customer acceptance range is provided.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | The device is intended for verification of calibration of the IDS-iSYS IGF-I assay. |
| Format | Lyophilized, same as predicate. |
| Unopened Stability | Store at 2-8°C until expiration date, same as predicate. |
| Analyte | IGF-I. (Difference from predicate, which uses hGH). |
| Levels | 4 levels. (Difference from predicate, which has 5 levels). |
| Matrix | Buffered protein. (Difference from predicate, which has human serum matrix). |
| Traceability | Traceable to the NIBSC code: 02/254 international standard. |
| Value Assignment | Mean value from valid runs (minimum 15 runs across at least 3 iSYS machines, with at least 3 runs per machine), with customer acceptance range based on 8% standard deviation from the mean. |
| Reconstituted Stability (on analyzer) | Up to 2.5 hours on the IDS-iSYS. (Difference from predicate, which has up to 5 hours). |
| Shelf-life Stability (unopened) | Initial shelf-life claim of 6 months at 2-8°C (supported by accelerated testing, real-time testing ongoing). |
| Reconstituted Stability (not on analyzer) | Not stored on board the analyzer. |
2. Sample Size Used for the Test Set and Data Provenance
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Test Set (Value Assignment):
- Minimum runs: At least 15 assay runs per lot.
- Minimum iSYS machines: At least 3 independent iSYS machines.
- Minimum runs per iSYS machine: At least 3 assay runs per iSYS machine.
- Samples/Controls per run: Tested in triplicate.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submitter is based in the United Kingdom, suggesting the study may have been performed there, but this is not confirmed. The study appears to be prospective as it involves active performance evaluation for value assignment and stability testing.
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Test Set (Stability):
- The sample size for stability testing (accelerated and real-time) is not explicitly detailed beyond stating that such testing was performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is an in vitro diagnostic (IVD) calibration verifier. The "ground truth" for IVD calibrators/verifiers is typically established through a rigorous value assignment process, often involving reference methods or traceability to international standards, rather than expert human interpretation of results like in medical imaging.
- Number of Experts: Not applicable in the traditional sense for establishing ground truth for this type of device. The "ground truth" (assigned value) is derived from the robust statistical analysis of multiple assay runs performed on the IDS-iSYS system, traceable to an international standard.
- Qualifications of Experts: Not applicable. The process relies on standardized laboratory procedures and statistical methods.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "final result reported is the mean value of all valid runs." This is a statistical aggregation method, not an adjudication process involving human experts resolving discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results (e.g., radiologists reading images) and the AI aims to assist or replace them. The IDS-iSYS IGF-I Calibration Verifier is a passive control material used in an automated analyzer, not an AI-powered diagnostic tool for human interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence, the performance evaluation is standalone (algorithm/device only). The device itself (the calibration verifier material) is evaluated for its intrinsic characteristics (value assignment and stability) using the IDS-iSYS automated analyzer. There is no human-in-the-loop performance being evaluated in the same way an AI diagnostic algorithm would be. The device's performance is gauged through its interaction with the automated assay system, independent of human interpretation of a diagnostic outcome.
7. The Type of Ground Truth Used
- Traceability to an International Standard and Statistical Mean of Multiple Assay Runs: The "ground truth" for the assigned values of the calibration verifier is established through its traceability to the NIBSC code: 02/254 international standard and by taking the mean value of all valid runs performed across multiple iSYS machines and assay kits. This is further qualified by a calculated "customer acceptance range" based on an 8% standard deviation.
8. The Sample Size for the Training Set
- Not applicable / Not explicitly detailed. As a calibration verifier, this device typically does not involve a "training set" in the context of machine learning. Its values are assigned through a standardized laboratory process (analytical validation), not by training a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a calibration verifier, there isn't a "training set" for model development. Its reference values are established through the process described in point 7.
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| Introduction | According to the requirements of 21CFR807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter | Immunodiagnostic Systems Ltd10 Didcot WayBoldon Business ParkBoldonTyne and WearNE35 9PDUnited Kingdom |
| Contact Person: Mick FentonPhone: +44 191 5190660Fax: +44 191 5190760Email: Michael.fenton@idsplc.com | |
| Secondary Contact: Dave MullingtonPhone: +44 191 5190660Fax: +44 191 5190760Email: david.mullington@sky.com | |
| Date prepared: August 03, 2012 | |
| Device Name | Proprietary name: IDS-iSYS IGF-I Calibration VerifierCommon name: IGF-I Calibration VerifierClassification: 21CFR862.1660, Single (specific) analyte controls (assayed and unassayed),Regulatory Class: Class I, reservedProduct Code: JJX |
| Predicate Device | The IDS-ISYS IGF-I Calibration Verifier is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys hGH CalCheck 5 (K103221) |
| Device Description | The IDS-iSYS IGF-I calibration verifer matrix is composed of a buffer solution containing bovine serum albumin with sodium azide as a preservative. The IGF-I peptide is added to this matrix and the resulting solution is lyophilised. |
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510(k) Summary continued
Intended Use The IDS-iSYS IGF-I calibration verifier is a device intended for the verification of calibration of the IDS-iSYS IGF-I assay when performed on the IDS-iSYS multi-disciplined automated analyzer.
Comparison Table
| Characteristic | IDS-iSYS IGF-ICalibration Verifiers(New Device) | Elecsys hGH CalCheck 5(Predicate Device)K103221 |
|---|---|---|
| Similarities | ||
| Intended use/Indications for use | Same | Used for assay calibrationverification. |
| Format | Same | Lyophilized |
| Unopened Stability | Same | Store at 2-8°C untilexpiration date |
| Differences | ||
| Analyte | IGF-I | hGH |
| Levels | 4 | 5 |
| Matrix | Buffered protein | Human serum matrix |
| ReconstitutedStability | On the analyzer:• up to 2.5 hours | On the analyzer:• up to 5 hours |
| PerformanceCharacteristics | The ID-iSYS IGF-I Calibration Verifier was evaluated for valueassignment and stability. See the following section for details. |
|---|---|
| Traceability | The IDS-iSYS IGF-I calibration verifier is traceable to the NIBSCcode: 02/254 international standard. |
| Value Assignment | IDS-iSYS IGF-I Calibration Verifiers value assignment is performedas follows.For each lot of the IDS-iSYS IS-3900 IGF-I assay kit available, aminimum of 15 assay runs is requested. Those runs must be performedusing at least 3 independent iSYS machines. A minimum of 3 assayruns per iSYS machine is required.Reagents, controls and samples are prepared according to the IDS-iSYS IGF-I Assay Instructions for Use IS-3900 and the IDS-iSYSIGF-I Control Set Instructions for Use IS-3930. |
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510(k) Summary continued
Each run consists of one iSYS calibration using the IDS-iSYS IGF-I IS-3900 Assay Reagent Cartridge, IDS-iSYS IGF-I IS-3900 Calibrators and the IDS-iSYS IS-3930 Control Set followed by samples (Calibration verifiers to test) and controls. Samples and controls are tested in triplicate.
For each Calibration Verifier, the final result reported is the mean value of all valid runs.
The customer acceptance range is calculated from the mean value based on 8% (standard deviation) for all Calibration Verifier.
Stability IDS-iSYS IGF-I Calibration Verifiers stability testing was/is performed on the IDS-iSYS automated analyzer. Shelf-life stability . The accelerated stability testing supports an initial shelf-life claim of 6 months at 2-8°C. Real time testing at 2-8°C is on-going. . Stability after reconstitution: Real time testing was performed and supports the following claims: Reconstituted IDS-iSYS IGF-I calibration verifiers are stable for up to 2.5 hours on the board the IDS-iSYS. The IDS-iSYS IGF-I calibration verifiers are not stored on board the analyzer. Conclusion The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three arms or branches extending upwards.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Immunodiagnostic Systems, Ltd. c/o Mick Fenton 10 Didcot Way Boldon Business Park Boldon, Tyne and Wear United Kingdom, NE35 9PD
AUG 7 2012
K122141 Re: K122141
Trade Name: IDS-iSYS IGF-I Calibration Verifier
Trade Name: IDS-iSYS IGF-I CEP 8862 1660 Trade Name: 1D CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed)
Regulation Name: Quality Control Material (assayed and unassayed)
1997 Name: Quality Control Material (assay Regulatory Class: Class I, reserved Product Codes: JJX Dated: July 16, 2012 Received: July 19, 2012
Dear Mr. Fenton:
Dour Court Section 510(k) premarket notification of intent to market the device is We have reviewed your Section SIU(K) premarket in substantially equivalent (for the
referenced above and have determined the device is substantially equivalent (for the referenced above and have detemined the device is substanced one ( - ) = ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = indications for use stated in the enclosure) in tegality the Medical Device in the Medical Device
interstate comments of the been been reclassified in accordance with the pro interstate commerce prior to May 28, 1976, the miaculies with the provisions of
Amendments, or to devices that have been recuassified in accordance with the provisions of Amendments, or to devices that have been reculass intention in and the premaikel
the Federal Food, Drug, and Cosmetic Act (Act (hat do not require approval of a premaint Paterial Food, Drug, and Cosmetic Act (Act) that do not require, subject to the peneral
approval Food, Drug, and Cosmetic Act (Act (Act its device, subject to the general approval application (PMA). You may, increity, innsvisions of the Act include
controls provisions of the Act. The general controls provisions of the Acti controls provisions of the Act. The general controls povisions of the more
requirements for annual registration, listing of devices, good manufacturing practice, for requirements for annual registration, noring of
on class III (see above) into either class II (Special Controls) on class III
n affective in the same and colditional controls. Existing major regulations affective If your device is classified (see above) into either class in (special or more)
(PMA), it may be subject to such additional controls. Existing major regulations affecting (PMA), it may be subject to such additional controls. Existing inalyon varios on 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 8 (111), world in Title 21, Code of Federal Regulations (Cricy), Farmer (1)
your device can be found in Title 21, Code of Federal Regulations (Crice in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's issuance of a substantial equirements with requirements
mean that FDA has made a determination that your device with other requirements. Fread that FDA has made a determination that your receral agencies.
of the Act or any Federal stations administered by other Federal agencies.
In registration block the Actil of the Act or any Eederal stantes and regulations administered by online of the Act of any the Act of any the Act of any the Act of any the You must comply with all the Act's requirements, including, our and listing (21 CFR Part 807); labeling (21 CFR 803); marting of the sola); and good
reporting (21 CFR Part 807); labeling (21 CFR 803); and good and hims (reporting of medical device-related adverse evenis) (21 CFR 000), and go
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
signature
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
K122141 K number
Device
IDS-iSYS IGF-I Calibration Verifier
The IDS-iSYS IGF-I Calibration Verifier is a device intended for verification of calibration of the IDS-iSYS IGF-I Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) = 1 2214
§ 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.