(54 days)
Not Found
No
The summary describes a calibration kit for blood cell analysis, which is a physical product containing stabilized cells. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML.
No
This device is a calibration and quality control product intended for laboratory use to verify reportable ranges for blood cell concentrations and ensure the accuracy of diagnostic tests, not to treat patients.
No
Explanation: The device is a calibration and linearity assessment kit for laboratory instruments, used to verify reportable ranges of blood components, not to diagnose a patient's condition.
No
The device description explicitly states it is a suspension of stabilized human blood components packaged in glass vials, indicating it is a physical reagent kit, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "calibration (linearity) assessment kit" for "white blood cell (WBC), red blood cell/hemoglobin (RBC/Hgb), and platelet (PLT) concentrations". It is used to "verify patient reportable ranges" and satisfy regulatory requirements (CLIA, CAP). This clearly indicates it is used in vitro (outside the body) to assess the performance of diagnostic instruments used to measure components of patient samples.
- Device Description: The description details a "suspension of stabilized human red blood cells, human white cells, and simulated platelets" packaged in vials. These are materials designed to be analyzed by laboratory instruments, not used directly on a patient.
- Performance Studies: The studies described (reproducibility, comparison with predicate, stability) are typical performance evaluations for IVD calibration and control materials.
- Predicate Device: The mention of a predicate device (K942822 CBC-LINE) which is also a calibration material for CBC parameters further supports its classification as an IVD.
While it doesn't directly diagnose a disease, it is a critical component used with diagnostic instruments to ensure the accuracy and reliability of the results obtained from patient samples. This function falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/hemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.
Product codes
Not Found
Device Description
CVA is a suspension of stabilized human red blood cells, human white cells, and simulated platelets (from mammalian red blood cells) packaged as separate components. CVA is supplied in glass vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
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)
Three studies of CVA were conducted: I) lot to lot reproducibility; II) within lot reproducibility and comparison with predicate product & whole blood; and III) long term and open vial stability. Study results showed CVA to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CBC-LINE (K942822)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
APR - 3 1996
510(k) Summary of Safety and Effectiveness
510(k) Submitter: Streck Laboratories, Inc. 14306 Industrial Road Omaha, Nebraska 68144
Official Correspondent: Theodore Heise, Ph.D. Quality Assurance/Regulatory Affairs Manager (402) 691-7465
February 8, 1996 Date Prepared:
Names of Device:
| Trade Name: | Calibration Verification Assessment (CVA) |
|---|---|
| Common Name: | Assayed hematology control |
| Classification Name: | Hematology quality control mixture (§864.8625) |
Predicate Device: CBC-LINE (K942822) R&D Systems, Inc.
Description: CVA is a suspension of stabilized human red blood cells, human white cells, and simulated platelets (from mammalian red blood cells) packaged as separate components. CVA is supplied in glass vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.
Intended Use: CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/hemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.
Comparison with Predicate Device:
| Parameter | CVA | CBC-LINE |
|---|---|---|
| WBC range | $0.5 - 90 \times 10^9/L$ | $9.0 - 90 \times 10^9/L$ |
| RBC range | $0.4 - 7.2 \times 10^{12}/L$ | $1.6 - 7.6 \times 10^{12}/L$ |
| PLT range | $15 - 900 \times 10^9/L$ | $100 - 1100 \times 10^9/L$ |
| HgB range | 1.2-22 g/dL | 4.5-23 g/dL |
| separate components | yes | yes |
| number of levels | four | six |
| assayed | yes | no |
- Discussion of Tests and Test Results: Three studies of CVA were conducted: I) lot to lot reproducibility; II) within lot reproducibility and comparison with predicate product & whole blood; and III) long term and open vial stability. Study results showed CVA to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating
- Conclusions Drawn from Tests: CVA is a safe and effective hematology control when used as instructed in the product package insert.