IDS-ISYS IGF-I CALIBRATION VERIFIERS

K122141 · Immunodiagnostic Systems , Ltd. · JJX · Aug 7, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122141
• Device Name: IDS-ISYS IGF-I CALIBRATION VERIFIERS
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 7, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Device Story

The IDS-iSYS IGF-I Calibration Verifier is a lyophilized matrix composed of a buffer solution, bovine serum albumin, sodium azide preservative, and IGF-I peptide. It is used on the IDS-iSYS multi-disciplined automated analyzer to verify the calibration of the IDS-iSYS IGF-I assay. The device is intended for clinical laboratory use. The operator performs a calibration run using the assay reagent cartridge, calibrators, and control set, followed by testing the verifiers in triplicate. The analyzer calculates the mean value of valid runs; the healthcare provider compares this result against a customer acceptance range (8% standard deviation) to confirm assay calibration accuracy. This process ensures the reliability of IGF-I measurements, which are critical for clinical decision-making regarding growth hormone-related disorders.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated through value assignment (minimum 15 runs across 3 independent analyzers) and stability testing. Accelerated shelf-life stability supports 6 months at 2-8°C; real-time stability testing is ongoing. Reconstituted stability on-board the analyzer is validated for up to 2.5 hours. Traceability established to NIBSC code 02/254 international standard.

Technological Characteristics

Lyophilized buffered protein matrix containing bovine serum albumin and sodium azide. 4 levels. Traceable to NIBSC 02/254. Designed for use on the IDS-iSYS automated analyzer. Stability: 6 months shelf-life at 2-8°C; 2.5 hours on-board stability after reconstitution.

Indications for Use

Indicated for verification of calibration of the IDS-iSYS IGF-I assay on the IDS-iSYS multi-disciplined automated analyzer. For prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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K122141

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AUG

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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 Ltd<br>10 Didcot Way<br>Boldon Business Park<br>Boldon<br>Tyne and Wear<br>NE35 9PD<br>United Kingdom |
| | Contact Person: Mick Fenton<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Secondary Contact: Dave Mullington<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Date prepared: August 03, 2012 |
| Device Name | Proprietary name: IDS-iSYS IGF-I Calibration Verifier<br>Common name: IGF-I Calibration Verifier<br>Classification: 21CFR862.1660, Single (specific) analyte controls (assayed and unassayed),<br>Regulatory Class: Class I, reserved<br>Product 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-I<br>Calibration Verifiers<br>(New Device) | Elecsys hGH CalCheck 5<br>(Predicate Device)<br>k103221 |
|--------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Similarities | | |
| Intended use/<br>Indications for use | Same | Used for assay calibration<br>verification. |
| Format | Same | Lyophilized |
| Unopened Stability | Same | Store at 2-8°C until<br>expiration date |
| Differences | | |
| Analyte | IGF-I | hGH |
| Levels | 4 | 5 |
| Matrix | Buffered protein | Human serum matrix |
| Reconstituted<br>Stability | On the analyzer:<br>• up to 2.5 hours | On the analyzer:<br>• up to 5 hours |

| Performance<br>Characteristics | The ID-iSYS IGF-I Calibration Verifier was evaluated for value<br>assignment and stability. See the following section for details. |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Traceability | The IDS-iSYS IGF-I calibration verifier is traceable to the NIBSC<br>code: 02/254 international standard. |
| Value Assignment | IDS-iSYS IGF-I Calibration Verifiers value assignment is performed<br>as follows.<br><br>For each lot of the IDS-iSYS IS-3900 IGF-I assay kit available, a<br>minimum of 15 assay runs is requested. Those runs must be performed<br>using at least 3 independent iSYS machines. A minimum of 3 assay<br>runs per iSYS machine is required.<br><br>Reagents, controls and samples are prepared according to the IDS-<br>iSYS IGF-I Assay Instructions for Use IS-3900 and the IDS-iSYS<br>IGF-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 [phone]. 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 [phone]. 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 [phone] or [phone] 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