(59 days)
Dimension® Drug Calibrator
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No
The device description and intended use clearly define it as a calibrator for in vitro diagnostic tests, a chemical product, with no mention of software, algorithms, or any AI/ML related terms.
No
The product is an "in vitro diagnostic product intended for the calibration of test methods," not for treating a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges."
No
The device description clearly states it is a liquid bovine serum base product containing purified drugs, packaged in vials. This indicates a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.
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.
Dimension® Drug Calibrator
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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§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image contains the word "DADE" in large, bold, black letters. Below the word "DADE" is the handwritten number "K962817". In the upper right corner of the image, the text "SEP 16 1986" is visible.
DADE INTERNATIONAL
Chemistry Systems P.O. Box 6101 Newark, DE 19714
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Drug Calibrator II
Summary of Safety and Effectiveness
Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEXTM reagent cartridges.
Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.
Drug Calibrator II is substantially equivalent to the Dimension® Drug Calibrator as they are both intended to be used as calibrators for drug methods and are spiked with purified drugs.
Carolyn K. George
Caroly K. George Regulatory Affairs and Compliance Manager
July 18, 1996
Date