(17 days)
No
The summary describes a control module for an immunoassay, which is a standard laboratory control material. There is no mention of AI, ML, or any computational analysis beyond potentially basic quality control calculations.
No.
The device is described as an "assayed, bi-level control intended for use with the IMMULITE® Anti-TPO Ab assay" and "strictly for in vitro diagnostic use." It is a control module for monitoring the performance of an assay, not for directly treating or diagnosing a medical condition in a patient.
Yes
The "Device Description" explicitly states, "It is intended strictly for in vitro diagnostic use."
No
The device description clearly states it is an "assayed, bi-level control" intended for use with an assay, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Device Description" section clearly states, "It is intended strictly for in vitro diagnostic use."
- Intended Use: The "Intended Use / Indications for Use" describes the device as an "aid in monitoring the performance of the IMMULITE® Anti-TPO Ab assay." This indicates it's used to evaluate the performance of another diagnostic test, which is a common function of IVD controls.
- Device Type: The device is described as a "control module," which is a type of product specifically designed for use in laboratory testing to ensure the accuracy and reliability of diagnostic assays.
Therefore, based on the provided information, this device is an IVD.
N/A
Intended Use / Indications for Use
IMMULITE® Thyroid Autoantibody Control Module is an assayed, bi-level control intended for use with the IMMULITE® Anti-TPO Ab assay. It is intended strictly for in vitro diagnostic use.
Product codes
75-JJX
Device Description
IMMULITE® Thyroid Autoantibody Control Module
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 applicable
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
Deagnostic Products Corporation IMMULITE® Thyroid Autoantibody Control Module March 21,1997
510 (k) Summary Safety and Effectiveness
APR 1 0 1997
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Name: Address:
Telephone Number: Facsimile Number: Contact Person:
Date of Preparation:
Device Name: Module Trade:
Catalog Number: Classification: Manufacturer:
Sole U.S. Importer:
Establishment Registration #:
Substantially Equivalent Predicate Device:
Description of Device: Intended Use of the Device:
Clinical Studies:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
(213) 776-0180 (213) 776-0204
Edward M. Levine, Ph.D.
Director of Clinical Affairs
March 21, 1997
IMMULITE® Thyroid Autoantibody Control
Device intended as an aid in monitoring the performance of the IMMULITE® Anti-TPO Ab assay.
LAACM
Class I device, 75-JJX (21 CFR 862.1660) EURO/DPC Ltd., a wholly-owned subsidiary of DPC Glyn Rhonwy Llanberis. Gwynedd LL55 4EL United Kingdom (Manufacturing under a Quality System-ISO 9002/EN29002/BS 5750)
Diagnostic Products Corporation (DPC) 5700 West 96th Street Los Angeles, CA 90045-5597
EURO/DPC: Not Applicable DPC: 2017183
DPC's PSA Control Module (K962975)
Quality Control Material
IMMULITE® Thyroid Autoantibody Control Module is an assayed, bi-level control intended for use with the IMMULITE® Anti-TPO Ab assay. It is intended strictly for in vitro diagnostic use.
Not applicable
1
Diagnostic Products Corporation IMMULITE® Thyroid Autoantibody Control Module March 21, 1997
Conclusion:
ﺳﻴﺪ
The conclusions drawn from the nopclinical tests demonstrate that the device is safe and effective.
Edward Laurie
Edward M. Levine, Ph.D. Director of Clinical Affairs
3/21/97
Date
Date
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