(77 days)
Dade ° Special-T" Marker
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No
The summary describes a quality control material for immunoassays, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No.
This device is a quality control material used to monitor the accuracy and precision of clinical immunoassays, not a device intended for treating or diagnosing patients.
No
Explanation: The device is described as a "quality control material" used to "monitor accuracy and precision in clinical immunoassays," not to diagnose a disease in a patient.
No
The device description clearly states it is a "lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing." This clearly indicates its use in a laboratory setting to evaluate the performance of diagnostic tests.
- Device Description: The description mentions it's prepared from "human blood" and used in "clinical immunoassays." These are hallmarks of materials used in in vitro diagnostic procedures.
- Predicate Device: The predicate device listed is a "Marker," which is consistent with a quality control material used in diagnostic testing.
The purpose of this device is to be used in vitro (outside the body) to assess the performance of other diagnostic tests (immunoassays for cancer antigens). This directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives.
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)
Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary.
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.
Dade ° Special-T" Marker, manufactured by Baxter Diagnostics Inc.
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
SCANTIBODIES LABORATORY, INC.
"SCANTIBODIES FOR ANTIBODIES"
KASSIA MAR 12 1996
510(k) Summary
| Submitter: | Tom Cantor
Scantibodies Laboratory, Incorporated
9336 Abraham Way, Santee, CA 92071-2862 |
|-------------------|------------------------------------------------------------------------------------------------|
| Date: | December 15, 1995 |
| Device Name: | SysCon (or other brand names) Tumor Marker Control |
| Predicate Device: | Dade ° Special-T" Marker, manufactured by Baxter Diagnostics Inc. |
Device Description:
This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives.
Intended use:
For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.
Comparison of the product to the predicate device for intended use, analytes, number of levels, form, diluent, base, additives, microbial content, lot homogeneity and vial-to-vial consistency, stability and reliability of assay values supports a substantial equivalence finding.
Performance data:
Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary.