IDS-iSYS CTX-I Calibration Verifiers

K143324 · Immunodiagnostic Systems , Ltd. · JJX · Mar 30, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143324
• Device Name: IDS-iSYS CTX-I Calibration Verifiers
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers is a device intended for the verification of calibration of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer. For Prescription use only

Device Story

IDS-iSYS CTX-I Calibration Verifiers consist of four vials of liquid horse serum containing human CTX-I at varying concentrations (0 to 6.6 ng/mL) and <0.1% sodium azide. Used in clinical laboratory settings by trained personnel to verify the calibration of the IDS-iSYS CTX-I Assay on the IDS-iSYS Multi-Discipline Automated Analyzer. The device serves as a quality control tool; healthcare providers use the output to confirm the analytical measurement range and calibration accuracy of the assay. Proper verification ensures the reliability of CTX-I measurements, which are used in clinical decision-making regarding bone turnover status.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (accelerated and real-time) confirmed a 12-month shelf life at 2-8°C and 3-hour on-board stability at 23°C±3°C. Value assignment was validated using the IDS-iSYS Multi-Discipline Automated Analyzer across multiple runs and analyzers.

Technological Characteristics

Liquid, ready-to-use calibration verification material. Matrix: heat-inactivated horse serum with <0.1% (w/w) sodium azide preservative. Contains human CTX-I. Four levels (0-3) with defined target ranges. Designed for use on the IDS-iSYS Multi-Discipline Automated Analyzer. Storage: 2-8°C.

Indications for Use

Indicated for use as a calibration verification material for the IDS-iSYS CTX-I (CrossLaps®) Assay on the IDS-iSYS Multi-Discipline Automated Analyzer. No specific patient population is described as this is an in vitro diagnostic quality control product.

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.

Predicate Devices

• IDS-iSYS CTX-I (Crosslaps®) Calibration Verifiers (k111650)

Submission Summary (Full Text)

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

March 30, 2015

IMMUNODIAGNOSTIC SYSTEMS LTD. ROMA YOUNG, REGULATORY AFFAIRS OFFICER 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR, NE35 9PD UNITED KINGDOM

Re: K143324

Trade/Device Name: IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: January 29, 2015 Received: February 6, 2015

Dear Roma Young:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) k143324

Device Name

IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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k143324

#### 510(k) SUMMARY

- According to the requirements of 21CFR807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Submitter Immunodiagnostic Systems Ltd 10 Didcot Way Boldon Business Park Boldon Tyne and Wear NE35 9PD United Kingdom
- Contact Person: Roma Young Phone: [phone] Fax: [phone] Email: [e-mail]
- Secondary Contact: Mick Fenton Phone: [phone] Fax: [phone] Email: [e-mail]
- March 23rd, 2015 Date Prepared:
- Device Name: Proprietary names: IDS-iSYS CTX-I (Crosslaps®) Calibration Verifiers Common names: As above
- Classification: 21CFR862.1660 (Class I, Reserved)

Product Code: JJX

- The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of Device Description: one set of four vials, 2.5 mL each in liquid form, containing horse serum with <0.1% (w/w) sodium azide as a preservative, with four concentration levels of human CTX-I:
Cal. Ver. 0: Undetectable Cal. Ver. 1: 0.12 - 0.16 ng/mL Cal. Ver. 2: 2.4 - 3.2 ng/mL Cal. Ver. 3: 5.6 - 6.6 ng/mL

- Predicate Device: IDS-iSYS CTX-I (Crosslaps ®) Calibration Verifiers
Predicate 510(k): k111650

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| Special Conditions<br>for Use: | For in vitro diagnostic use; for prescription use. |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Special instrument<br>Requirements: | IDS-iSYS Multi-Discipline Automated Analyzer |
| Intended Use: | The IDS-iSYS CTX-1 (CrossLaps®) Calibration Verifiers is a device<br>intended for the verification of calibration of the IDS-iSYS CTX-1<br>(CrossLaps®) Assay when performed on the IDS-iSYS Multi-<br>Discipline Automated Analyzer. |

# Comparison with predicate:

| Similarities | Predicate Device | Candidate Device |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The IDS-iSYS CTX-I<br>CrossLaps®) Calibration<br>Verifiers is a device intended<br>for the verification of<br>calibration of the IDS-iSYS<br>CTX-I (CrossLaps ®) Assay<br>when performed on the IDS-<br>iSYS multi-disciplined<br>automated analyzer. | Same |
| Analyte | CTX-I | Same |
| Values | Cal. Ver. 0: 0.0 ng/mL<br>Cal. Ver. 1: 0.6 ng/mL<br>Cal. Ver. 2: 3.0 ng/mL<br>Cal. Ver. 3: 5.0 ng/mL | Cal. Ver. 0: Undetectable<br>Cal. Ver. 1: 0.12 - 0.16 ng/mL<br>Cal. Ver. 2: 2.4 - 3.2 ng/mL<br>Cal. Ver. 3: 5.6 - 6.6 ng/mL |
| Levels | Levels 0, 1, 2, 3 | Same |
| Analyzer System | IDS-iSYS Multi-Discipline<br>Automated Analyzer | Same |
| Stability | 2-8°C - unopened until<br>expiration date<br>On board stability: Single use-<br>use then discard | 2-8°C - unopened until<br>expiration date<br>On board stability: 3 hours,<br>single use only. |
| Differences | Predicate device | Candidate device |
| Matrix | Liquid, phosphate bovine<br>serum albumin | Horse serum containing CTX-I<br>and sodium azide as preservative<br>(<0.1%). 1 vial each of levels 0-3<br>(2.5 mL). |

Table 1

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## Performance Characteristics

### Traceability and Value Assignment

The IDS-iSYS CTX-I assay is standardized against in-house reference standards (CTX-I in horse serum). Four levels of calibrator verifiers were used to validate the calibration on the IDS-iSYS and validate the range of the analytical measurement. Each lot-specific value assignment was tested in five runs on at least three different IDS-iSYS analyzers in triplicate, for a total of 45 replicates. The assigned target value of each calibrator verifier was defined as the mean of all the runs for each calibrator verifier. The guideline target range is defined as the mean of all runs ± 2SD.

The following target mean values and ranges for each calibrator verifier provided in Table 2 are typical for the product and are intended as a guide only. Values may vary from lot to lot.

| CVM | Target Mean<br>(ng/mL) | Standard Deviation<br>(SD) | Target Range<br>(ng/mL) |
|-------------|------------------------|----------------------------|-------------------------|
| Cal. Ver. 0 | 0 (Undetectable) | NA | NA |
| Cal. Ver. 1 | 0.14 | 0.009 | 0.12 - 0.16 |
| Cal. Ver. 2 | 2.8 | 0.168 | 2.4 - 3.2 |
| Cal. Ver. 3 | 6.1 | 0.366 | 5.6 - 6.6 |

#### Table 2

### Stability

On board stability studies in accordance with the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) were performed with kit calibrators and controls. 250ul of each were placed in 500ul cups. Five sets of calibration verifiers were placed on board. At each of five time points (T0=0, T1=1h, T2=2h, T3=3h and T4=4.5h) one set was tested. The concentrations of samples were interpolated from a validated 2point calibration. Data produced supports a claim of three hours on board stability.

Accelerated stability studies performed in accordance with the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) using two point calibration support a shelf life stability claim of twelve months.

All acceptance criteria were met.

Real time stability studies in accordance with the CLSI guideline EP25-A (Evaluation of stability of In Vitro Diagnostic Reagents) to support the above claims are ongoing.

### Proposed Labeling

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

### Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.