K Number
K083655
Device Name
ELECSYS TOXO IGG CALCHECK
Manufacturer
Date Cleared
2009-02-12

(64 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.
Device Description
The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of human anti-Toxo IgG antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
More Information

Not Found

No
The document describes a calibrator control for an immunoassay analyzer, which is a standard laboratory product and does not mention any AI or ML components.

No.
The device is an assayed calibrator control used for verifying the calibration of immunoassay analyzers, not for treating or diagnosing diseases.

No

Explanation: The device is described as an "assayed calibrator control" intended for "verification of the calibration established by the Elecsys Toxo IgG reagent." Its purpose is to ensure the accuracy of other diagnostic reagents, not to directly diagnose a condition in a patient.

No

The device description clearly states it is a "lyophilized product consisting of human anti-Toxo IgG antibodies in human serum matrix," indicating it is a physical reagent, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's an "assayed calibrator control" for verifying the calibration of an IVD reagent (Elecsys Toxo IgG reagent) on specific immunoassay analyzers. This clearly indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
  • Device Description: The description mentions it's a "lyophilized product consisting of human anti-Toxo IgG antibodies in human serum matrix." This is a typical composition for a control or calibrator used in laboratory testing.
  • 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. Calibrators and controls are essential components of IVD systems.

While the document doesn't contain all the information typically found in an IVD submission (like performance metrics, patient age range, etc.), the core function and intended use as a calibrator control for an immunoassay clearly place it within the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

For use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.

Product codes

JJX, LGD

Device Description

The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of human anti-Toxo IgG antibodies in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.

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

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Elecsys Toxo IgG CalCheck was evaluated for value assignment and stability.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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.

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K083655

FEB 1 2 2009

510(k) Summary

Introduction

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

Submitter name, address, contact

Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 317-521-3208

Contact Person: Kelly French

Date Prepared: November 20, 2008

Device Name

Proprietary name: Elecsys Toxo IgG CalCheck

Common name: Toxo IgG CalCheck

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

Predicate device

The Elecsys Toxo IgG CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck (K040157).

The Elecsys Toxo IgG CalCheck is a lyophilized product consisting of Device human anti-Toxo IgG antibodies in human serum matrix. During Description manufacture, the analytes are spiked into the matrix at the desired concentration levels.

For use in the verification of the calibration established by the Elecsys Toxo Intended use IgG reagent on the Elecsys and cobas e immunoassay analyzers.

Continued on next page

1

510(k) Summary, Continued

The table below compares Elecsys Toxo IgG CalCheck with the predicate Comparison device, Elecsys C-Peptide Calcheck (K040157). Table and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the

| Characteristic | Elecsys C- Peptide CalCheck
(K040157) | Elecsys Toxo IgG 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
Toxo IgG reagent on the 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 standing closed for 15
minutes, then mixing gently. | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20 - 25 °C : 4 hrs | Same |
| Matrix | equine serum matrix | Human serum |

Performance Characteristics The Elecsys Toxo IgG CalCheck was evaluated for value assignment and stability.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 eagle emblem with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kelly French Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-3831

.

Re: K083655

Trade/Device Name: Elecsys Toxo IgG CalCheck Regulation Number: 21 CFR 862.1660 21 CFR 866.3780

Regulation Name: Quality control material (assayed and unassayed) Toxoplasma gondii serological reagents

FEB 1 2 2009

Regulatory Class: I, II Product Code: JJX, LGD Dated: December 9, 2008 Received: December 10, 2008

Dear Ms. French:

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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

3

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Felly A. Uejinet, M.D., Ph.D.

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

4

Indication for Use

K083653 510(k) Number (if known):

Device Name: Elecsys Toxo IgG CalCheck

Indication For Use:

The Elecsys Toxo IgG CalCheck, as assayed calibrator control, is intended for use in the verification of the calibration established by the Elecsys Toxo IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers.

ਮ Prescription Use (21 CFR Part 801 Subpart D)

And/Or

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 (OVD)

freddie hi. Poole

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

510(k) K083653