Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a calibration material for an immunoassay analyzer and does not mention any AI or ML components.

Therapeutic

No.
The device is a calibrator used to verify the calibration of an immunoassay analyzer and does not directly treat or diagnose a disease.

Diagnostic

No

Explanation: The device is a calibrator intended for verifying the calibration of a CA 19-9 reagent on immunoassay analyzers. It does not directly diagnose a medical condition in a patient.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "lyophilized product consisting of CA 19-9 in a buffered human serum matrix," indicating it is a physical reagent, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for "verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers." This indicates it's used in a laboratory setting to ensure the accuracy of a diagnostic test (the Elecsys® CA 19-9 reagent).
Device Description: The description mentions it's a "lyophilized product consisting of CA 19-9 in a buffered human serum matrix." This is a common format for calibrators and controls used in in vitro diagnostic tests.
Predicate Device: The predicate device listed (K040157; Elecsys® C-Peptide CalCheck™) is also a CalCheck product, which are typically classified as IVDs used for calibration verification in diagnostic testing.

While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and the nature of the predicate device strongly indicate that this product is used in a laboratory setting to support the accuracy of an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Product codes

JJX

Device Description

The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered 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

Not Found

Summary of Performance Studies

The Elecsys® CA 19-9 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

Regulation Number and Section

§ 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.

Summary

0

K 051185

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
317-521-3723
	Contact Person: Corina Harper
	Date Prepared: May 6, 2005
Device Name	Proprietary name: Elecsys® CA 19-9 CalCheck™
	Common name: CA 19-9 CalCheck
	Classification name: Single (specified) analyte controls (assayed and unassayed)
Predicate device	The Elecsys® CA 19-9 CalCheck™ is substantially equivalent to the currently marketed Elecsys® C-Peptide CalCheck™ (K040157).
Device Description	The Elecsys® CA 19-9 CalCheck™ is a lyophilized product consisting of CA 19-9 in a buffered human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
Intended use	Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
	Continued on next page

:

1

510(k) Summary, Continued

| Comparison to
predicate
device | The Elecsys® CA 19-9 CalCheck™ is substantially equivalent to the
currently marketed Elecsys® C-Peptide CalCheck™ (K040157). The below
tables compare Elecsys® CA 19-9 CalCheck™ with the predicate device,
Elecsys® C-Peptide CalCheck™ (K040157). |

--------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Similarities

| Characteristic | Elecsys® CA 19-9
CalCheck™ | Predicate device
Elecsys® C-Peptide
CalCheck™ |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® CA 19-9
CalCheck™ is intended
for use in the verification
of the calibration
established by the
Elecsys® CA 19-9
reagent on the Elecsys®
1010/2010/MODULAR
ANALYTICS E170
immunoassay analyzers. | Elecsys® C-Peptide
CalCheck is intended for
use in the verification of
the calibration established
by the Elecsys® C-Peptide
reagent on the Elecsys®
immunoassay systems. |
| 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 |

Continued on next page

2

510(k) Summary, Continued

Differences

| Characteristic | Elecsys® CA 19-9
CalCheck™ | Predicate device
Elecsys® C-Peptide
CalCheck™ |
|----------------|-----------------------------------|-----------------------------------------------------|
| Matrix | Human serum with added
CA 19-9 | Buffered horse serum with
added C-Peptide |

Performance	The Elecsys® CA 19-9 CalCheck™ was evaluated for value assignment and
Characteristics	stability.

3

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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circle around the caduceus symbol.

Public Health Service

JUL 6 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. c/o Ms Corina Harper 9115 Hague Rd. Indianapolis, IN 46250

Re: K051185

Trade/Device Name: Elecsys CA 19-9 CalCheck Regulation Number: 21 CFR 866.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: May 6, 2005 Received: May 9, 2005

Dear Ms Harper:

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 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 Part 801); 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.

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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

4

Page 2 -

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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

5

Indications for Use

510(k) Number (if known): __K051185

Device Name:_Elecsys® CA_19-9 CalCheck™

Indications For Use:

The Elecsys® CA 19-9 CalCheck™ is intended for use in the verification of the calibration established by the Elecsys® CA 19-9 reagent on the Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.

Maria Chen

Division Sign-Off

Office of In Vitro Diagne Device Evaluation and Sately

510(k) K'o.s.j.i.l.s

Prescription Use XX = __

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)