(27 days)
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No
The document describes a lyophilized control product for immunoassay analyzers and does not mention any AI or ML components or functionalities.
No
The device is an assayed control used for calibration verification and assay range verification for an in vitro diagnostic test, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use only." While it is a control for a diagnostic assay, it is an integral part of the diagnostic process.
No
The device description clearly states it is a lyophilized product consisting of SHBG in human and equine serum matrix, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states "for in vitro diagnostic use only." This is the most direct indicator.
- Function: The device is a control used for calibration verification and assay range verification of a quantitative assay reagent (Elecsys SHBG). These are essential steps in ensuring the accuracy and reliability of in vitro diagnostic tests.
- Device Description: The description mentions it's a lyophilized product containing SHBG in a serum matrix, designed to be used with immunoassay analyzers. This aligns with the nature of materials used in in vitro diagnostic testing.
The information provided strongly supports the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Elecsys SHBG 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 SHBG quantitative assay 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 SHBG CalCheck 5 is a lyophilized product consisting of SHBG in human and equine (horse) serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 SHBG CalCheck 5 was evaluated for value assignment and Performance Characteristics stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
KI1349
| 510(k) Summary | JUN - 9 2011 |
|---|---|
| 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 French | |
| Phone: 317-521-3208 | |
| Fax: 317-521-2324 | |
| Email: kelly.french@roche.com | |
| Secondary Contact: Stephanie Greeman | |
| Phone: 317-521-2458 | |
| Fax: 317-521-2324 | |
| Email: stephanie.greeman@roche.com | |
| Date Prepared: May 11, 2011 | |
| Device Name | Proprietary name: Elecsys SHBG CalCheck 5 |
| Common name: SHBG CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and | |
| unassayed) | |
| Predicate | |
| device | The Elecsys SHBG CalCheck 5 is substantially equivalent to other products |
| in commercial distribution intended for similar use. We claim equivalency to | |
| the currently marketed SHBG CalCheck (K031698). | |
| Device | |
| Description | The Elecsys SHBG CalCheck 5 is a lyophilized product consisting of SHBG |
| in human and equine (horse) serum matrix. During manufacture, the analyte | |
| is spiked into the matrix at the desired concentration levels. | |
| Intended use | The Elecsys SHBG 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 SHBG quantitative assay reagent on the indicated Elecsys and | |
| cobas e immunoassay analyzers, for in vitro diagnostic use only. | |
| Continued on next page |
510(k) Summary
1
510(k) Summary, Continued
Comparison Table
The table below compares Elecsys SHBG CalCheck 5 with the predicate device, Elecsys SHBG CalCheck (K031698). The predicate shows that SHBG CalCheck 5 is substantially equivalent to SHBG CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.
| Characteristic | Elecsys SHBG
CalCheck 5
(Candidate Device) | Elecsys SHBG CalCheck
(K031698) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys SHBG
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
SHBG quantitative assay
reagent on the indicated
Elecsys and cobas e
immunoassay analyzers. | For use in the verification of
the calibration established by
the Elecsys SHBG regent on
Elecsys
1010/2010/MODULAR
ANALYTICS E170
immunoassay analyzers. |
| Analyte | SHBG | SHBG |
| Levels | Five | Three |
| Assay Measuring
Range | $0.800-200$ nmol/L | $0.350 - 200$ nmol/L |
| Check Target
Values | Check 1: $