(29 days)
CalCheck Vitamin D Total II
This section is not found in the text.
No
The summary describes a calibration control set for an immunoassay analyzer and does not mention any AI/ML components or functionalities.
No
The device is described as an "assayed control for use in calibration and for use in the verification of the assay range" of another diagnostic test, not for treating a disease or condition.
No
The device is described as an "assayed control for use in calibration and for use in the verification of the assay range" of another diagnostic device (Elecsys ß-CrossLaps/serum reagent), and for "calibration verification and the assessment of the measuring range". It is explicitly stated as a "customer convenience product and not required to assess the performance." This indicates it's a quality control/calibration product for an immunoassay analyzer, not a device that directly diagnoses a patient's condition.
No
The device is a physical control material (lyophilized) used for calibration and verification of an immunoassay analyzer, not a software program.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It describes the product as being used for "calibration verification and the assessment of the measuring range." These are standard functions of IVD control materials.
- Performance Studies: The document details performance studies related to stability and value assignment, which are typical for IVD products to ensure their reliability and accuracy.
- Predicate Device: The mention of a "Predicate Device" (CalCheck Vitamin D Total II) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device.
While the device description mentions it's a "customer convenience product and not required to assess the performance," this doesn't negate its classification as an IVD. It's a control material used in conjunction with an IVD assay (Elecsys ß-CrossLaps/serum reagent) to ensure the accuracy and reliability of that assay's results. Control materials used in this context are considered IVDs themselves.
N/A
Intended Use / Indications for Use
This CalCheck set is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys B-CrossLaps/serum reagent on the cobas e immunoassay analyzers.
Product codes
JJX
Device Description
The ß-CrossLaps CalCheck 5 is used for the calibration verification and the assessment of the measuring range as needed by the laboratory certification agencies such as College of American Pathologists or CLIA certification. The CalChecks are a customer convenience product and not required to assess the performance.
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 ß-CrossLaps CalCheck 5 matrix, human serum, is identical to the Master Calibrators (human serum sample panel) used for the Elecsys ß-CrossLaps/serum assay.
ß-CrossLaps CalCheck 5 was evaluated for value assignment and stability.
Value Assignment: For each ß-CrossLaps CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least two (2) modules (each with two measuring cells) of the cobas e 801 with at least two runs. The assigned value of each CalCheck is defined as the median value obtained over at least six (6) determinations (runs) of the respective CalCheck. The CalCheck assigned range is calculated as ± 27% of the assigned value for levels 2 through 5.
Target Values:
Check 1: ≤0.05 ng/mL
Check 2: 0.5 ng/mL
Check 3: 3.0 ng/mL
Check 4: 4.5 ng/mL
Check 5: 6.0 ng/mL
Stability Studies: Studies were performed to verify stability claims.
Study 1: Open vial stability. Reconstituted material stored for 4 hours at 25°C. Acceptance criterion for CalCheck Level 1 was
§ 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
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2017
ROCHE DIAGNOSTICS EDIE BRUNT PRINCIPAL, REGULATORY AFFAIRS 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K170678
Trade/Device Name: ß-CrossLaps CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: March 3, 2017 Received: March 6, 2017
Dear Edie Brunt:
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170678
Device Name B-CrossLaps CalCheck 5
Indications for Use (Describe)
This CalCheck set is an assayed control for use in calibration and for use in the verification of the assay range established by the Elecsys B-CrossLaps/serum reagent on the cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and comblete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
ß-CrossLaps CalCheck 5 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k).
The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the ß-CrossLaps CalCheck 5.
| Submitter Name | Roche Diagnostics |
|---|---|
| Address | 9115 Hague Road |
| P.O. Box 50416 | |
| Indianapolis, IN 46250-0457 | |
| Contact | Edie Brunt |
| Phone: (317) 521-4668 | |
| FAX: (317) 521-2324 | |
| Email: edie.brunt@roche.com | |
| Date Prepared | March 3, 2017 |
| Proprietary Name | ß-CrossLaps CalCheck 5 |
| Common Name | Beta-CrossLaps CalCheck 5 |
| Classification Name | Single (Specified) Analyte Controls (Assayed and Unassayed)) |
| Product Codes, | |
| Regulation Numbers | JJX, 862.1660 |
| Predicate Devices | CalCheck Vitamin D Total II |
| Establishment Registration | For the B-CrossLaps CalCheck 5, the establishment registration number for |
| Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and for | |
| Penzberg, Germany, 9610529. The establishment registration number for Roche | |
| Diagnostics in the United States is 1823260. |
4
1. DEVICE DESCRIPTION
The ß-CrossLaps CalCheck 5 is used for the calibration verification and the assessment of the measuring range as needed by the laboratory certification agencies such as College of American Pathologists or CLIA certification. The CalChecks are a customer convenience product and not required to assess the performance.
INDICATIONS FOR USE 2.
This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers.
TECHNOLOGICAL CHARACTERISTICS 3.
The following table compares the ß-CrossLaps CalCheck 5 with its predicate device, CalCheck Vitamin D Total II (K162840).
CalCheck Comparison Table 1:
| Feature | CalCheck Vitamin D Total II | β-CrossLaps CalCheck 5 |
|---|---|---|
| Intended Use/Indications for Use | This CalCheck set is an assayed | |
| control for use in calibration | ||
| verification and for use in the | ||
| verification of the assay range | ||
| established by the Elecsys | ||
| Vitamin D total II reagent on the | ||
| cobas e 411 immunoassay | ||
| analyzer. | This CalCheck set is an assayed | |
| control for use in calibration | ||
| verification and for use in the | ||
| verification of the assay range | ||
| established by the Elecsys β- | ||
| CrossLaps/serum reagent on the | ||
| cobas e immunoassay analyzers. | ||
| Analyte | 25-hydroxyvitamin D3 | Synthetic β-CTx peptide in a |
| CrossLaps free human serum | ||
| matrix | ||
| Matrix | Human serum | Same |
| Levels | Five | Same |
5
| Feature | CalCheck Vitamin D Total II | ß-CrossLaps CalCheck 5 |
|---|---|---|
| Target Ranges | Approximate target | |
| concentrations: | ||
| Check 1: ≤ 5 ng/mL | ||
| Check 2: 17.5 — 22.4 ng/mL | ||
| Check 3: 46.5 - 54.4 ng/mL | ||
| Check 4: 75.5 - 84.4 ng/mL | ||
| Check 5: 94.5 -> 100 ng/mL | Approximate target | |
| concentrations: | ||
| Check 1: ≤ 0.05 ng/mL | ||
| Check 2: 0.4-0.6 ng/mL | ||
| Check 3: 2.7 - 3.3 ng/mL | ||
| Check 4: 4.0 - 5.0 ng/mL | ||
| Check 5: 5.4 ->6.0 ng/mL | ||
| Format | Lyophilized | Same |
| Handling | Reconstitute the contents of each | |
| CalCheck vial with exactly 1.0 | ||
| mL distilled or deionized water. | ||
| Allow the bottles to stand closed | ||
| for 15 minutes. Mix gently by | ||
| inversion to ensure homogeneity. | Same | |
| Storage and Stability | Reconstituted control serum: | |
| At 20-25°C - 4 hours | Same |
NON-CLINICAL PERFORMANCE EVALUATION 4.
The ß-CrossLaps CalCheck 5 matrix, human serum, is identical to the Master Calibrators (human serum sample panel) used for the Elecsys ß-CrossLaps/serum assay.
ß-CrossLaps CalCheck 5 was evaluated for value assignment and stability.
Value Assignment 4.1.
For each ß-CrossLaps CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least two (2) modules (each with two measuring cells) of the cobas e 801 with at least two runs. The assigned value of each CalCheck is defined as the median value obtained over at least six (6) determinations (runs) of the respective CalCheck.
The CalCheck assigned range is calculated as ± 27% of the assigned value for levels 2 through 5. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use.
6
Target Values
| β-CrossLaps CalCheck 5 Level | Target Value [ng/mL] |
|---|---|
| Check 1 | ≤0.05 |
| Check 2 | 0.5 |
| Check 3 | 3.0 |
| Check 4 | 4.5 |
| Check 5 | 6.0 |
4.2. Stabilitv
The following studies were performed in order to verify the stability claims for the ß-CrossLaps CalCheck 5:
Study 1: Open vial stability
Study 2: Accelerated stability
Study 3: Real-time stability
4.2.1. Open Vial Stability
The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 4 hours at 25℃ (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The on-test recovery was calculated as a percent of the reference value. The acceptance criterion for CalCheck Level 1 was