(39 days)
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No
The summary describes a liquid chemistry control used to monitor laboratory testing precision. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies focus on the stability of the control material itself.
No
The device is a liquid control serum used to monitor the precision of laboratory testing procedures, not to treat or prevent disease.
No
Explanation: The "Intended Use / Indications for Use" states that this device monitors the precision of laboratory testing procedures, not that it is used to diagnose a disease or condition in a patient. It is a control serum used to evaluate the accuracy of other diagnostic tests.
No
The device description explicitly states it is a liquid control serum prepared from human serum and other biochemical materials, indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in the package insert." This is a classic function of an IVD control material.
- Device Description: It's a "human liquid control serum" used in "laboratory testing procedures." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control, controls are essential components of IVD testing.
- Predicate Device: The mention of a predicate device (K011867; Liquid Assayed Multiqual Control Levels 1, 2, and 3) which is also a control material, further supports its classification as an IVD. Predicate devices are legally marketed devices that are substantially equivalent to the new device, and in the context of medical devices, this typically refers to other IVDs.
- Performance Studies: The performance studies described (stability testing) are typical evaluations performed on IVD control materials to ensure their reliability and suitability for use in laboratory testing.
Therefore, the information provided strongly indicates that CONE-TROL Liquid Chemistry Control is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Product codes
JJY
Device Description
CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.
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)
The closed vial stability of CONE-TROL Liquid Chemistry Control at 2-8°C has been determined from real time stability testing. CONE-TROL Liquid Chemistry Control was stored closed vial at 2-8°C, as described in the package insert, for 33 days. Results indicate acceptable stability through 33 days.
The open vial stability of CONE-TROL Liquid Chemistry Control at 2-8°C has been determined from real time stability testing. After opening, CONE-TROL Liquid Chemistry Control was stored at 2-8°C for 15 days. To simulate expected handling conditions, vials were removed from refrigerator daily (excluding weekends), opened, and returned to refrigerator. Results indicate acceptable stability through 15 days.
The shelf life of CONE-TROL Liquid Chemistry Control at
§ 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.
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SECTION V
JUL 2 4 2012
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Submitter:
Cone Bioproducts 1012 N. Austin Street Seguin, TX 78155
Telephone: (830)379-0197 Facsimile: (830)379-0471
Contact Person:
William K. Cone President Telephone: (830)379-0197 ext. 203 Facsimile: (839)379-0471
Preparation Date:
June 1, 2012
Device Information:
Proprietary Name: Regulation Section: Product Code: Classification: Panel:
CONE-TROL Liquid Chemistry Control 21 CFR 862.1660 Control JJY - Multi-analyte Control Class I, Reserved Clinical Chemistry (75)
Device to Which Substantial Equivalence is Claimed:
Liquid Assayed Multiqual Control Levels 1, 2, and 3 Bio-Rad Laboratories Irvine, California 510(k) Number: K011867
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Device Description:
CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.
Intended Use:
CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Comparison to Predicate Device(s):
The CONE-TROL Liquid Chemistry Control is substantially equivalent to Liquid Assayed Multiqual Control (K011867) for its stated intended use.
| Device
Characteristics | Subject Device | Predicate Device(s)
K011867 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert. | Liquid Assayed Multiqual Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Analyte(s) | Albumin, Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Apolipoprotein A-1, Apolipoprotein B, Aspartate Aminotransferase, Bicarbonate, Bilirubin-Direct, Bilirubin-Total, Blood Urea Nitrogen, Complement 3, Complement 4, C-Reactive Protein, Calcium, Cholesterol, HDL Cholesterol, LDL Cholesterol, Cholinesterase, Creatinine Kinase, Chloride, Creatinine, Gamma Glutamyltransferase, Glucose, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Lactate, Lactate Dehyrdogenase, Haptoglobin, Iron, Unsaturated Iron Binding Capacity, Magnesium, Phosphorous, Potassium, Prealbumin, Sodium, Total Protein, Transferrin, Triglycerides, Uric Acid | All analytes in subject device plus the analytes listed below:
Acetaminophen, Acid Phosphatase, a-1-Antitrypsin, aHBDH, Amikacin, Carbamazepine, Ceruloplasmin, CK- MB, Copper, Cortisol, Digoxin, Ethanol, Gentamicin, Globulin, Iron Binding Capacity-Total, LAP Arylamidase, Lipase, Lithium, Osmolality, Phenobarbital, Phenytoin, Phospholipids, Prostatic Acid Phosphatase, Protein Electrophoresis, Salicylate, T3-Total, T3-Free, T4-Total, T4- Free, T-Uptake, Theophylline, Thyroid Stimulating Hormone, Tobramycin, Urea, Valproic Acid, Vitamin B12, Zinc |
| Matrix | Human Serum | Human Serum |
| Control Form | Liquid | Liquid |
| Levels | 2 | 3 |
| Storage | -20°C or colder | -20°C or colder |
| (Unopened Frozen) | Until expiration date | Until expiration date |
Table V-1: Device Comparison Table
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| Storage
(Unopened Thawed) | 2-8°C
30 days | 2-8°C (current Package Insert)
30 days with the following exceptions:
Direct Billirubin - 11 days,
Triglycerides, HDL, Cholinesterase,
and Phosphorous - 7 days. Total and
Direct Bilirubin values may decrease,
Alkaline phosphatase activity may rise.
The control must be stored frozen when
using AST methods without pyridoxal-
5-phosphate. |
|------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Storage
(Open, Thawed) | 2-8°C for 14 days. | 2-8°C (current Package Insert)
14 days with the following exceptions:
Direct Bilirubin, Triglycerides, HDL,
Cholinesterase, and Phosphorous will
be stable for 7 days and LAP
Arylamidase will be stable for 3 days. |
Value Assignment
CONE-TROL Liquid Chemistry Control is value assigned on the Abaxis Piccolo Express Analyzer using Piccolo Xpress panels. Each panel is a self-contained plastic disc with reagents. Intelligent Quality Control and bar coded calibration are built in to each reagent disc. The panels used to value assign CONE-TROL Liquid Chemistry Control include but are not limited to: t. Seat 10 vas. Cat. No. 400-0030; Hepatic Panel, Cat. No. 400-0026; General Chemistry 13, Cat. No. 400-0029; Renal Panel Plus, Cat. No. 400-0027; Basic Metabolic Panel Plus, Cat. No. 400-0031; Liver Panel Plus, Cat. No. 400-0003; Metlyte +CRP, Cat. No. 400-0034.
Endogenous analytes were value assigned on the Roche Cobas Mira Plus and Mindray BS-200 using Kamiya and Sekisui reagents.
Values are assigned by assaying 6 randomly selected vials from each manufacturing lot. Vials are measured in duplicate and across 2 or more instruments for each Abaxis Xpress panel listed above. Value assigument is performed within 30 days of manufacturing date. Vials used for value assignment are to be tested within 5 days after product is thawed.
Performance Testing:
The closed vial stability of CONE-TROL Liquid Chemistry Control at 2-8°C has been determined from real time stability testing. CONE-TROL Liquid Chemistry Control was stored closed vial at 2-8°C, as described in the package insert, for 33 days. Results indicate acceptable stability through 33 days.
The open vial stability of CONE-TROL Liquid Chemistry Control at 2-8°C has been determined from real time stability testing. After opening, CONE-TROL Liquid Chemistry Control was stored at 2-8°C for 15 days. To simulate expected handling conditions, vials were removed from refrigerator daily (excluding weekends), opened, and returned to refrigerator. Results indicate acceptable stability through 15 days.
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The shelf life of CONE-TROL Liquid Chemistry Control at