(28 days)
No
The summary describes a calibration material for an assay and does not mention any AI or ML components.
No
This device is used to verify the calibration of an assay, not to treat a medical condition. It's a quality control material rather than a therapeutic instrument.
No
The device is used to verify the calibration of an assay, not to diagnose a patient's condition.
No
The device description explicitly states it is a set of "lyophilized, human based materials," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that it is used to "verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay." This means it is used in vitro (outside the body) to assess the performance of another diagnostic test (the Elecsys PSA assay).
- Device Description: The description mentions it is a "set of lyophilized, human based materials" that are "assayed in triplicate." This further confirms it is a reagent or material used in a laboratory setting for testing.
- Predicate Device: The predicate device listed (Elecsys® CalCheck™ TSH) is also a CalCheck product, which are typically used for calibration verification in IVD assays.
Therefore, based on the provided information, the Boehringer Mannheim Elecsys CalCheck PSA fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay.
Product codes
Not Found
Device Description
The Elecsys® CalCheck™ PSA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR - 6 1997
| 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. |
|---|---|
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation |
| 2400 Bisso Lane | |
| Concord, CA 94524-4117 | |
| (510) 827 - 8215 | |
| Fax number: (510) 687-1850 | |
| Contact Person: Patricia M. Klimley | |
| Date Prepared: January 29, 1997 | |
| 2. Device Name | Proprietary name: Elecsys® CalCheck™ PSA |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3. Predicate device | The Elecsys® CalCheck™ PSA is substantially equivalent to currently marketed, Elecsys® CalCheck™ TSH (K963147). |
| 4. Device Description | The Elecsys® CalCheck™ PSA is a three level single analyte set of lyophilized, human based materials. After reconstitution, they are assayed in triplicate and the results compared to the target values. |
Continued on next page..............................................................................................................................................................................
510(k) Summary
. ..
er
1
510(k) Summary, Continued
| 5.
| Intended use | The Boehringer Mannheim Elecsys CalCheck PSA is used to verify the calibration assignment for the Boehringer Mannheim Elecsys PSA assay. | ||
|---|---|---|---|
| 6. | |||
| Comparison | |||
| to predicate | |||
| device | The Elecsys® CalCheck™ PSA is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). |
The following table compares the Elecsys® CalCheck™ PSA with the predicate device, Elecsys® CalCheck™ TSH. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate devices is provided in attachment 6.
Similarities: | | |
• Configuration: 3 CalCheck levels: low, mid, and high
• Intended use: To verify calibration
Differences:
|
An and announce of the driver and any and any and the commend of the comments of the county
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 14 1 1 6 6 0 0 0 0 000
CALLERIES
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ER LAND LIGHTMLE
| . |
|---|
| CARANT COLORIO COLOR COLLEGION |
A control confidential color do all | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| --------------------------------------- |
|---|
.
Acres of the Artist program and
- | Comment Commend Court Court Court Court and Concellente Company of Children Collection Collection Come of Children Collection Collection Collection Come of Children Collectio
.
10-10-02-2012 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000
AND REALER & RESERVE LEA MENSION MENSE A MARKET DE A MARKET DE A BE
of consisted and the contract and the production and any and any and any | .
Separate Station Come of Children Comers
MI I (MBA) MI (LE MILL ME & ME COME (MI
Company of Children Children of Children |
Continued on next page
2
510(k) Summary, Continued
Performance Characteristics: Comparison to predicate device, (cont.)
• Value assignment and stability