(141 days)
Not Found
No
The summary describes a calibration control product for an immunoassay, which is a standard laboratory reagent and does not involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The "Intended Use" states that the device is "For in vitro diagnostic use only", indicating it is used for testing purposes outside the body, not for treating or preventing disease.
No
This device is described as an "assayed control" used for calibration verification and verification of assay range. It is not used to diagnose a patient but rather to ensure other diagnostic devices are functioning correctly. The statement "For in vitro diagnostic use only" refers to the context in which it's used (for diagnostics) rather than the device itself being a diagnostic tool.
No
The device description clearly states it is a "lyophilized product consisting of human CA 19-9 in human serum matrix," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is the primary indicator that the device is intended for use in testing biological samples outside of the body to diagnose or monitor a medical condition.
N/A
Intended Use / Indications for Use
The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 19-9 reagent on the indicated Elecsys and cobas e immunoassay analyzers. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of human CA 19-9 in human serum matrix. During manufacture, the analyte is 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys CA 19-9 CalCheck 5 was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 101367
バ
| 510(k) Summary | OCT - |
|---|---|
| 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, P.O. Box 50416 | |
| Indianapolis, IN 46250-0416 | |
| 317-521-3577 | |
| Contact Person: Kelly Colleen O'Maine Adams | |
| Phone: 317-521-3577 | |
| Fax: 317-521-2324 | |
| Email: colleen.adams@roche.com | |
| Secondary Contact: Stephanie Greeman | |
| Phone: 317-521-2458 | |
| Fax: 317-521-2324 | |
| Email: stephanie.greeman@roche.com | |
| Date Prepared: September 27, 2010 | |
| Device Name | Proprietary name: Elecsys CA 19-9 CalCheck 5 |
| Common name: CA 19-9 CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and | |
| unassayed) | |
| Predicate | |
| device | The Elecsys CA 19-9 CalCheck 5 is substantially equivalent to other products |
| in commercial distribution intended for similar use. We claim equivalency to | |
| the currently marketed Elecsys C-Peptide CalCheck 5 (K100810) and CA 19- | |
| 9 CalCheck (K051185). | |
| Device | |
| Description | The Elecsys CA 19-9 CalCheck 5 is a lyophilized product consisting of |
| human CA 19-9 in human serum matrix. During manufacture, the analyte is | |
| spiked into the matrix at the desired concentration levels. | |
| Intended use | The Elecsys CA 19-9 CalCheck 5 is an assayed control for use in calibration |
| verification and for use in the verification of the assay range established by | |
| the Elecsys CA 19-9 reagent on the indicated Elecsys and cobas e | |
| immunoassay analyzers. For in vitro diagnostic use only. |
1
510(k) Summary, Continued
Comparison The table below compares Elecsys CA 19-9 CalCheck 5 with the predicate Table devices, Elecsys C-Peptide CalCheck 5 (K100810) and CA 19-9 CalCheck (K051185). The first predicate shows that CA 19-9 CalCheck 5 is substantially equivalent to another CalCheck 5 product, Elecsys C-Peptide CalCheck 5. The Elecsys CA 19-9 CalCheck 5 is also substantially equivalent to the second predicate, CA 19-9 CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and one or both predicate devices.
| Characteristic | Elecsys C-Peptide
CalCheck 5 (K100810) | Elecsys CA 19-9
CalCheck 5
(Candidate Device) | Elecsys CA 19-9
CalCheck
(K051185) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys C-Peptide
CalCheck 5 is an assayed
control for use in calibration
verification and for use in
the verification of the serum
and plasma assay range
established by the Elecsys
C-Peptide reagent on the
indicated Elecsys and cobas
e immunoassay analyzers. | The Elecsys CA 19-9
Calcheck 5 is an assayed
control for use in
calibration verification and
for use in the verification
of the assay range
established by the Elecsys
CA 19-9 reagent on the
indicated Elecsys and
cobas e immunoassay
analyzers. For in vitro
diagnostic use only. | For use in the verification of
the calibration established by
the Elecsys CA 19-9 reagent
on the indicated Elecsys and
cobas e immunoassay
analyzers. |
| Analyte | C-Peptide | CA 19-9 | CA 19-9 |
| Levels | Five | Five | Three |
| Assay Measuring
Range | 0.1 - 40 ng/mL | 0.600 - 1000 U/mL | 0.600 - 1000 U/mL |
| Check Target
Values | Check 1: