K Number
K091601
Device Name
ELECYS ANTI-CCP CALCHECK
Date Cleared
2009-09-25

(114 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Device Description
The Elecsys Anti-CCP CalCheck is a lyophilized product consisting of human antibodies to cyclic citrullinated peptide (CCP) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Once reconstituted, this solution is used to verify the calibration established by the Elecsys Anti-CCP reagent on the Elecsys and cobas e immunoassay analyzers.
More Information

Not Found

No
The summary describes a calibration verification product for an immunoassay analyzer, which is a chemical reagent and not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts.

No.
The device is described as a product for verifying the calibration of a reagent used on immunoassay analyzers, rather than for treating or diagnosing a medical condition.

No

This device is a calibrate check, designed to verify the calibration of immunoassay analyzers, not to diagnose a medical condition in a patient.

No

The device description clearly states it is a "lyophilized product consisting of human antibodies... in human serum matrix," which is a physical, non-software component.

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's "For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of another diagnostic test (the Elecsys Anti-CCP reagent).
  • Device Description: The description details a "lyophilized product consisting of human antibodies to cyclic citrullinated peptide (CCP) in human serum matrix." This is a biological material designed to be used in a laboratory setting with an immunoassay analyzer.
  • Function: The device is used to "verify the calibration" of a diagnostic reagent. This is a quality control function essential for ensuring the accuracy and reliability of an in vitro diagnostic test.
  • Predicate Device: The mention of a predicate device (K040157; Elecsys C-Peptide CalCheck) which is also a "CalCheck" product, further supports its classification as an IVD, as predicate devices are typically other legally marketed devices of the same type.

While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and function clearly align with the definition of an IVD device. It's a reagent used in vitro to assess the performance of another diagnostic test.

N/A

Intended Use / Indications for Use

For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Product codes

JJX

Device Description

The Elecsys Anti-CCP CalCheck is a lyophilized product consisting of human antibodies to cyclic citrullinated peptide (CCP) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Once reconstituted, this solution is used to verify the calibration established by the Elecsys Anti-CCP reagent on the Elecsys and cobas e immunoassay analyzers.

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

Not Found

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

The Elecsys Anti-CCP CalCheck was evaluated for value assignment and stability.

Key Metrics

Not Found

Predicate Device(s)

K040157

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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.

0

K091/601

SEP % 5 2009

510(k) Summary

2.1 1

According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence.

Roche Diagnostics Submitter name, address, contact

9115 Hague Road Indianapolis, IN 46250

Contact Person: Sarah Baumann Phone: 317-521-3952 Fax: 317-521-2324 Email: sarah.baumann@roche.com

Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com

Date Prepared: June 1, 2009

Proprietary name: Elecsys Anti-CCP CalCheck Device Name

Common name: Anti-CCP CalCheck

Classification name: Single (specified) analyte controls (assayed and unassayed)

the currently marketed Elecsys C-Peptide CalCheck (K040157).

Predicate device

Device Description

The Elecsys Anti-CCP CalCheck is a lyophilized product consisting of human antibodies to cyclic citrullinated peptide (CCP) in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Once reconstituted, this solution is used to verify the calibration established by the Elecsys Anti-CCP reagent on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Anti-CCP CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to

Continued on next page

Confidential

1

1

510(k) Summary, Continued

少 : ****

Intended use For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.

The table below compares Elecsys Anti-CCP CalCheck with the predicate Comparison Table device, Elecsys C-Peptide Calcheck (K040157).

| Characteristic | Elecsys C- Peptide CalCheck
(K040157) | Elecsys Anti-CCP CalCheck |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the verification of the
calibration established by the
Elecsys C-Peptide reagent on the
Elecsys and cobas e immunoassay
analyzers. | For use in the verification of the
calibration established by the Elecsys
Anti-CCP reagent on the indicated
Elecsys and cobas e immunoassay
analyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mL
distilled or deionized water and
allow to stand closed for 15
minutes, then mix gently by
inversion. | Same |
| Stability | Unopened:
Store at 2-8℃ until expiration
date
Reconstituted:
20—25°C : 4 hrs | Same |
| Matrix | Equine serum | Human serum |

The Elecsys Anti-CCP CalCheck was evaluated for value assignment and Performance Characteristics stability.

2

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The overall design is simple and recognizable.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Roche Diagnostics Corporation c/o Sarah Baumann 9115 Hague Road Box 50140 Indianapolis, IN 46250-0457

SEP % 5 2009

K091601 Re:

Trade/Device Name: Elecsys Anti-CCP CalCheck Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: September 8, 2009 Received: September 14, 2009

Dear Sarah Baumann:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

3

Page 2

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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

G. C. H

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

4

Indication for Use

510(k) Number (if known):

Device Name: Elecsys Anti-CCP CalCheck

Indication For Use:

For use in the verification of the calibration established by the Elecsys Anti-CCP reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Ör

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Cawl Benson

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K09/601