(10 days)
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Not Found
No
The summary describes a control module for an immunoassay, which is a standard laboratory reagent, and contains no mention of AI or ML.
No
This device is an in vitro diagnostic control for monitoring the performance of an assay, not for treating a patient.
Yes
The device description states, "It is intended strictly for in vitro diagnostic use," indicating it is a diagnostic device used for monitoring the performance of an assay.
No
The device description clearly states it is an "assayed, bi-level control" intended for in vitro diagnostic use, indicating it is a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Device intended as an aid in monitoring the performance of DPC's IMMULITE ACTH assay."
Furthermore, the "Device Description" section states: "It is intended strictly for in vitro diagnostic use."
These statements clearly indicate that the device is intended for use in vitro (outside of a living organism) for diagnostic purposes (monitoring the performance of an assay used in diagnosis).
N/A
Intended Use / Indications for Use
Device intended as an aid in monitoring the performance of DPC's IMMULITE ACTH assay. DPC's IMMULITE ACTH Control Module is an assayed, bi-level control intended for use with DPC's IMMULITE ACTH assay. It is intended strictly for in vitro diagnostic use.
Product codes
JJX
Device Description
Quality Control Material
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
Not Found
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
Diagnostic Products Corporation 5700 West 96th Street Angeles, CA 90045 (213) 776-0180
IS 2 9 1908
510 (k) Summary Safety and Effectiveness
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: Trade:
Catalog Number: Classification: Manufacturer:
Establishment Registration Number: Description of Device: Intended Use of the Device:
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
August 15, 1996
IMMULITE ACTH Control Module Device intended as an aid in monitoring the performance of DPC's IMMULITE ACTH assay.
LACCM
Class I device, 82-JJX (21 CFR 862.1660)
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
DPC's Registration Number is 2017183
Quality Control Material
DPC's IMMULITE ACTH Control Module is an assayed, bi-level control intended for use with DPC's IMMULITE ACTH assay. It is intended strictly for in vitro diagnostic use.
Clinical Studies:
Not applicable
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective.
Edward A. Lewis
Edward M. Levine, Ph.D. Director of Clinical Affairs
8/12/9
Date