(22 days)
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No
The document describes a calibration control for an immunoassay analyzer and does not mention any AI or ML components.
No
Explanation: The device is an "assayed control for use in calibration verification and for use in the verification of the assay range" of an immunoassay, and is explicitly stated "for in vitro diagnostic use only." It is not used to treat a disease or condition.
No
The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range." It is used to verify the performance of a diagnostic assay (Elecsys PTH quantitative assay reagent), rather than directly diagnosing disease.
No
The device description clearly states it is a lyophilized product consisting of human PTH 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 / Indications for Use: The statement explicitly says "for in vitro diagnostic use only."
- Device Description: The description of the product (lyophilized human PTH in human serum matrix) and its purpose (calibration verification and assay range verification) aligns with the function of an IVD control.
- Predicate Device: The mention of a predicate device (K993642; Elecsys PTH CalCheck) which is also an IVD control further supports this classification.
The device is designed to be used in vitro (outside the body) to assess the performance of an in vitro diagnostic assay (the Elecsys PTH quantitative assay). This is a key characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Elecsys PTH 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 PTH 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 PTH CalCheck 5 is a lyophilized product consisting of human PTH in human 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 PTH CalCheck 5 was evaluated for value assignment and 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.
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NOV 1 8 2010
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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact 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: October 11, 2010 Device Name Proprietary name: Elecsys Parathyroid Hormone CalCheck 5 Common name: PTH CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassaved) Predicate The Elecsys PTH CalCheck 5 is substantially equivalent to other products in device commercial distribution intended for similar use. We claim equivalency to the currently marketed PTH CalCheck (K993642). Device The Elecsys PTH CalCheck 5 is a lyophilized product consisting of human Description PTH in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys PTH 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 PTH quantitative assay reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
510(k) Summary
Continued on next page
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510(k) Summary, Continued
Comparison Table
The table below compares Elecsys PTH CalCheck 5 with the predicate device, Elecsys PTH CalCheck (K993642). The predicate shows that PTH CalCheck 5 is substantially equivalent to PTH CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and the predicate device.
| Characteristic | Elecsys PTH CalCheck
5
(Candidate Device) | Elecsys PTH CalCheck
(K993642) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys PTh 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 PTH
quantitative assay reagent
on the indicated Elecsys
and cobas e immunoassay
analyzers. For in vitro
diagnostic use only. | For use in periodic
verification of the calibration
of the Elecsys Parathyroid
Hormone test. |
| Analyte | PTH | PTH |
| Levels | Five | Three |
| Assay Measuring
Range | 1.20 - 5000 pg/mL | 1.20 - 5000 pg/mL |
| Check Target
Values | Check 1: ≤ 1 pg/mL
Check 2: 60 pg/mL
Check 3: 2500 pg/mL
Check 4: 4000 pg/mL
Check 5: 5000 pg/mL | Check 1: