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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria for performance metrics. However, we can infer the implicit "acceptance criteria" and how the device's performance aligns with them based on the stability testing described. The primary "performance" being evaluated here is the stability of the control material over time under various storage conditions.

Acceptance Criteria (Inferred)	Reported Device Performance (CONE-TROL Liquid Chemistry Control)
Closed Vial Stability (2-8°C): Control material remains stable for at least 30 days at 2-8°C (matching predicate).	Acceptable stability through 33 days at 2-8°C (real-time testing).
Open Vial Stability (2-8°C): Control material remains stable for at least 14 days at 2-8°C after opening (matching predicate).	Acceptable stability through 15 days at 2-8°C after opening and simulating handling (real-time testing).
Shelf Life (Frozen <-20°C): Control material remains stable until expiration date at <-20°C (matching predicate).	Acceptable stability through 254 days at <-20°C (real-time testing). Real-time studies are ongoing to support the shelf life.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Value Assignment: 6 randomly selected vials from each manufacturing lot were assayed in duplicate across 2 or more instruments for each Abaxis Xpress panel. "Endogenous analytes" were value assigned using Kamiya and Sekisui reagents, but the specific number of vials/measurements for this is not explicitly stated, although it implies a similar process.
- Performance (Stability) Testing: The document does not specify the exact number of vials or lots used for the real-time stability studies. It mentions "CONE-TROL Liquid Chemistry Control was stored..." (singular phrasing), which could imply a limited number of samples, but it doesn't give a concrete count.
Data Provenance: The studies were conducted by Cone Bioproducts, so the data is likely generated within the United States. The studies are described as "real-time stability testing," indicating they are prospective in nature, as the control material was monitored over time under specified conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (liquid chemistry control) does not typically involve expert review for "ground truth" in the same way an imaging or diagnostic AI device would. The "ground truth" for a chemistry control is established through:

Assigned Values: These are determined by assaying the control material on validated instruments (Abaxis Piccolo Express Analyzer, Roche Cobas Mira Plus, Mindray BS-200) using established methods and reagents.
Stability: This is determined by comparing measured values at different time points to initial values, adhering to established analytical chemistry principles.

Therefore, there were no "experts" in the traditional sense involved in establishing a ground truth for interpretation based on subjective judgment. The "truth" is derived from analytical measurements performed by trained technicians or laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for this type of device is based on quantifiable analytical measurements and stability parameters, not on subjective interpretations requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a medical device for quality control in chemistry testing, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a chemical quality control material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" used for this device is based on analytical measurements and stability data against predetermined ranges or expectations for various analytes as measured by laboratory equipment. It ensures that the control material maintains its integrity and assigned values over time under specified conditions.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. This is a manufactured product (chemistry control) whose performance is evaluated against established analytical methods and specifications, not an algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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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:

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.

DeviceCharacteristics	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°C30 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 andDirect Bilirubin values may decrease,Alkaline phosphatase activity may rise.The control must be stored frozen whenusing 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 willbe stable for 7 days and LAPArylamidase 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 <-20°C has been determined from real time stability testing. CONE-TROL Liquid Chemistry Control was stored closed vial at -20°C, as described in the package insert, for 254 days. Results indicate acceptable stability through 254 days. Real time studies will be ongoing to support the shelf life of this product.

Summary:

The information provided in this pre-market notification demonstrates that CONE-TROL Liquid Chemistry Control is substantially equivalent to Liquid Assayed Multiqual Control (K011867). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate device. The information supplied in this pre-market notification provides reasonable assurance that the CONE-TROL Liquid Chemistry Control is safe and effective for its stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a high-contrast image.

10903 New Hampshire Avenue Silver Spring, MD 20993

JUL 2 4 2012

Cone Bioproducts c/o William K. Cone 1012 N. Austin St. Sequin, TX 78155

K121759 Re:

Trade Name: CONE-TROL Liquid Chemistry Controls Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: June 1, 2012 Received: June 15, 2012

Dear Mr. Cone:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

S. X. Liu, Ph.D.

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K121759

CONE-TROL Liquid Chemistry Controls Device name:

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rte Clu

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

! 21759 510(k)

Page 1 of 1

Regulation Number and Section

§ 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.