(77 days)
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No
The document describes quality control and calibration verification materials for hematocrit analyzers, which are chemical reagents, not software or hardware incorporating AI/ML. There is no mention of AI, ML, or related concepts in the provided text.
No
Explanation: The device is described as a quality control and calibration verification material for hematocrit analyzers, not a device used for treating a disease or condition.
No
Explanation: The device is a quality control and calibration verification material for hematocrit analyzers, not a diagnostic device itself. Its purpose is to verify the performance and calibration of other devices that perform diagnostic measurements.
No
The device description clearly states the product is a "bi-level quality control material" and "calibration verification material" provided in "2.5 mL ampules," indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the materials are for "use with hematocrit analyzers" as "quality control material" and "calibration verification material." These are classic functions of IVD devices used to ensure the accuracy and reliability of diagnostic tests performed on biological samples.
- Device Description: The description further clarifies that the materials are "uniquely formulated to provide quality control values" and "formulated to verify the calibration" of hematocrit analyzers. This reinforces their role in the diagnostic process.
- Nature of the Materials: Quality control and calibration verification materials are used in vitro (outside the body) to assess the performance of diagnostic instruments that analyze biological samples (in this case, blood for hematocrit).
The fact that it doesn't mention image processing, AI, DNN, or ML, and the other sections are "Not Found" or "Not Applicable" is consistent with it being a relatively straightforward IVD material used for quality control and calibration, rather than a complex diagnostic imaging or AI-powered device.
N/A
Intended Use / Indications for Use
The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges.
Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.
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)
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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.
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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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§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
JUL 26 1996
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
| Contact person: | William J. Pignato |
|---|---|
| Director of Regulatory Affairs |
Address: Chiron Diagnostics Corp. 63 North Street Medfield, MA 02052
508 359-3825 Phone:
April 25, 1996 Date Summary Prepared:
2. Device Information
| Proprietary Name: | Certain® Hct and CVM™ Hct |
|---|---|
| Common Name: | Hematocrit quality control and calibration |
| verification materials | |
| Classification Name: | Quality Control Material (assayed & unassayed) |
| Calibration Verification Material | |
| Classification Number: | 21 CFR 862.1660 |
3. Predicate Device Information
| Name: | GEM critCheck |
|---|---|
| Manufacturer: | Mallinckrodt |
| 510(k) Number: |
4. Device Description
The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verfication of analyzer hematocrit performance within established ranges.
Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.
1
5. Statement of Intended Use
The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.
6. Summary of Technological Characteristics
Certain® Hct and CVM™ Hct are assayed aqueous based bicarbonate solution and other salts.