(76 days)
Not Found
No
The device description and intended use clearly describe a liquid stable control material for monitoring assay conditions, with no mention of AI or ML technologies.
No
The device is described as a "control material" and "test sample" for monitoring assay conditions in clinical laboratory determinations. Its purpose is to ensure the consistent performance of reagents and instruments used in assays, not to directly treat or diagnose a patient's medical condition, which is the function of a therapeutic device.
No
The device is a control material used to monitor the performance of diagnostic assays, not a diagnostic device itself.
No
The device description clearly states the product is a liquid stable control material prepared from human serum, 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 clearly states that the product is for "monitoring assay conditions in many clinical laboratory determinations" and is to be included "with patient serum specimens." This directly aligns with the definition of an IVD, which is a device intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or for the assessment of health.
- Device Description: The description confirms it's a "liquid stable control material prepared from human serum," further supporting its use in laboratory testing of human samples.
- Intended User / Care Setting: The intended user is the "clinical laboratory," which is the typical setting for IVD use.
- Predicate Device(s): The listed predicate devices (MAS® chemTRAK®H, DADE® Moni-Trol® H and OLYMPUS Chemistry Control) are all known IVD control materials. This strongly suggests that the current device falls into the same category.
The fact that it's a "control material" used to monitor the performance of other diagnostic assays within a clinical laboratory setting is a key indicator of its IVD status. It's not a diagnostic test itself, but it's an essential component used in vitro to ensure the accuracy and reliability of diagnostic testing.
N/A
Intended Use / Indications for Use
chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and other non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, AST/GOT, CK and lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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
SEP 2 1 2009
510K SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92
The assigned 510(k) number is: K092051
COMPANY/CONTACT PERSON
Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific Specialty Diagnostics Division, CDx Fremont 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 office (510) 979-5422 fax
DATE PREPARED
July 16, 2009
DEVICE NAME
Trade Names:
Thermo Scientific MAS® chemTRAK® H Liquid Assayed Chemistry Controls Thermo Scientific Moni-Trol® H Liquid Assayed Chemistry Controls
Common Names:
chemTRAK® H Liquid Assayed Chemistry Controls Moni-Trol® H Liquid Assayed Chemistry Controls
Device Classification: Class | -
Classification Panel: Quality Control Material (Assayed and Unassayed) for Clinical Chemistry
Requlation number: 21 CFR 862.1660
Product Code: JJY
INTENDED USE:
chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations
1
with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE
Thermo Scientific MAS® chemTRAK® H and Thermo Scientific Moni-Trol® H are substantially equivalent to the previously cleared MAS® chemTRAK®H, DADE® Moni-Trol® H and OLYMPUS Chemistry Control (K030942)
DESCRIPTION OF DEVICE
This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and other non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, AST/GOT, CK and lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.
| Comparison | Predicate Device, K030942 | Modified Device, K092051 |
|---|---|---|
| Intended Use | chemTRAK® H is intended for | |
| use as a consistent test sample | ||
| of known concentration for | ||
| monitoring assay conditions in | ||
| many clinical laboratory | ||
| determinations. Include | ||
| chemTRAK® H with patient | ||
| serum specimens when | ||
| assaying for any of the listed | ||
| constituents. The user can | ||
| compare observations with | ||
| expected ranges as a means of | ||
| assuring consistent | ||
| performance of reagent and | ||
| instrument. | chemTRAK® H is intended for | |
| use as a consistent test sample | ||
| of known concentration for | ||
| monitoring assay conditions in | ||
| many clinical laboratory | ||
| determinations. Include | ||
| chemTRAK® H with patient | ||
| serum specimens when | ||
| assaying for any of the listed | ||
| constituents. The user can | ||
| compare observations with | ||
| expected ranges as a means of | ||
| assuring consistent | ||
| performance of reagent and | ||
| instrument. | ||
| Moni-Trol® H is intended for use | ||
| as a consistent test sample of | ||
| known concentration for | Moni-Trol® H is intended for use | |
| as a consistent test sample of | ||
| known concentration for | ||
| Description of | ||
| device | monitoring assay conditions in | |
| many clinical laboratory | ||
| determinations. Include Moni- | ||
| Trol® H with patient serum | ||
| specimens when assaying for | ||
| any of the listed constituents. | ||
| The user can compare | ||
| observations with expected | ||
| ranges as a means of assuring | ||
| consistent performance of | ||
| reagent and instrument. | monitoring assay conditions in | |
| many clinical laboratory | ||
| determinations. Include Moni- | ||
| Trol® H with patient serum | ||
| specimens when assaying for | ||
| any of the listed constituents. | ||
| The user can compare | ||
| observations with expected | ||
| ranges as a means of assuring | ||
| consistent performance of | ||
| reagent and instrument. | ||
| Matrix | This product is a liquid stable | |
| control material prepared from | ||
| human serum. | This product is a liquid stable | |
| control material prepared from | ||
| human serum. | ||
| Storage | ||
| Condition | -20°C | -20°C |
Comparison of Technological Characteristics
2
:
| Analyte
List | Predicate Device
K030942 | Modified Device
Proposed Analytes
(Modifications in bold) |
|---------------------------|---------------------------------------------|-----------------------------------------------------------------|
| | Acetaminophen | Acetaminophen |
| | Acid Phosphatase* | Acid Phosphatase* |
| | Albumin | Albumin |
| | Alkaline Phosphatase, ALP | Alkaline Phosphatase, ALP |
| | Alanine Aminotransferase, ALT | Alanine Aminotransferase, ALT |
| | Alpha-Fetoprotein, AFP* | Alpha-Fetoprotein, AFP* |
| | Amikacin | Amikacin |
| Analyte | Amylase | Amylase |
| List, Cont. | Apolipoprotein A (APO A)* | Apolipoprotein A (APO A) * |
| | Apolipoprotein B (APO B)* | Apolipoprotein B (APO B) * |
| | Aspartate Aminotransferase, AST | Aspartate Aminotransferase, AST |
| | Bilirubin, Direct | Bilirubin, Direct |
| | Bilirubin, Total | Bilirubin, Total |
| | Blood Urea Nitrogen, BUN | Blood Urea Nitrogen, BUN |
| | Caffeine | Caffeine |
| | Calcium | Calcium |
| | Carbamazepine | Carbamazepine |
| | Carbon Dioxide, CO2 | CO2 |
| | C3 Compliment | C3 Complement* |
| | C4 Compliment | C4 Complement* |
| | C-Reactive Protein, CRP | C-Reactive Protein, CRP* |
| | Chloride | Chloride |
| | Cholesterol | Cholesterol |
| | Creatine Kinase, CK | Creatine Kinase, CK |
| | Creatinine | Creatinine |
| | Cyclosporine* | |
| | Digoxin | Digoxin |
| | Disopyramide | Disopyramide |
| | Ethanol | Ethanol |
| | Ethosuximide | Ethosuximide |
| | Ferritin | Ferritin* |
| | Thiiodothyronine Free T3 | Thiiodothyronine Free T3* |
| | Thyroxine Free T4 | Thyroxine Free T4* |
| | Gamma Glutamyltransferase, GGT | Gamma Glutamyltransferase, GGT |
| | Gentamicin | Gentamicin |
| | Glutamate Dehydrogenase, | Glutamate Dehydrogenase, |
| | GLDH* | GLDH* |
| | Glucose | Glucose |
| | Haptoglobin* | Haptoglobin* |
| | Hydroxybutyrate Dehydrogenase,
HBDH* | Hydroxybutyrate Dehydrogenase,
HBDH* |
| | High Density Lipoprotein | High Density Lipoprotein |
| | Cholesterol, HDL | Cholesterol, HDL |
| | Human Chorionic Gonadotrophin,
hCG | Human Chorionic Gonadotrophin,
hCG* |
| | Immunoglobulin A, IgA | Immunoglobulin A, IgA* |
| | Immunoglobulin G, IgG | Immunoglobulin G, IgG* |
| | lmmunoglobulin M, IgM | lmmunoglobulin M, IgM* |
| | Iron | Iron |
| | Lactate Dehydrogenase, LDH | LDH |
| | Lactic Acid | Lactic Acid |
| | Lidocaine | Lidocaine |
| Analyte
List,
Cont. | Lipase | Lipase
Lipoprotein (LpA)* |
| | Lithium | Lithium |
| | Low Density Lipoprotein
Cholesterol, LDL | LDL-Cholesterol |
| | Magnesium | Magnesium |
| | Methotrexate | Methotrexate |
| | N-Acetylprocainamide, NAPA | N-Acetylprocainamide, NAPA |
| | Osmolality | Osmolality |
| | Phenobarbital | Phenobarbital |
| | Phenytoin | Phenytoin |
| | Phosphorus | Phosphorus |
| | Potassium | Potassium |
| | Prealbumin | Prealbumin |
| | Primidone | Primidone |
| | Procainamide | Procainamide |
| | Prostate Specific Antigen, PSA | - |
| | Pseudocholinesterase, PCHE | Pseudocholinesterase |
| | Quinidine | Quinidine |
| | Salicylate | Salicylate |
| | Sodium | Sodium |
| | Theophylline | Theophylline |
| | Thyroid Stimulating Hormone, TSH | Thyroid Stimulating Hormone, TSH |
| | Thyroxine, Total T4 | Thyroxine, Total T4 |
| | Tobramycin | Tobramycin |
| | Total Iron Binding Capacity, TIBC | Iron Binding Capacity, Total |
| | Total Protein | Total Protein |
| | Transferrin | Transferrin* |
| | Tricyclic Antidepressants | Tricyclic Antidepressants |
| | Triglycerides | Triglycerides |
| | Thiiodothyronine, Total T3 | Thiiodothyronine, Total T3* |
| | T-Uptake | T-Uptake |
| | Uric Acid | Uric Acid |
| | Valproic Acid | Valproic Acid |
| | Vancomycin | Vancomycin |
| | Unsaturated Iron Binding Capacity
(UIBC) | Unsaturated Iron Binding Capacity
(UIBC)* |
3
and the comments of the comments of the comments of
1999 - 1999 - 1999
4
:
.
:
.
:
.
,
:
Analytes are added, however no claims are made
.
:
:
. . . .
:
.
.
♦ Analytes are not added, as found in the source material.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
MicroGenics Corporation. Thermo Fisher Scientific c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538
SEP 2 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
· Re: K092051
Trade Name: Thermo Scientific MAS® chemTRAK® H Liquid Assayed Chemistry Controls, Thermo Scientific Moni-Trol® H Liquid Assayed 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: July 1. 2009
Received: July 7, 2009
Dear Ms. Charter:
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).
6
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/MedicalDevices/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indication for Use
510(k) Number: K092051
Device Name:
Thermo Scientific MAS® chemTRAK® H Liquid Assayed Chemistry Controls Thermo Scientific Moni-Trol® H Liguid Assayed Chemistry Controls
Indication For Use:
chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent . and instrument.
Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol® H with patient serum specimens when assaving for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Prescription Use
And/Or
Over the Counter Use
(21 CFR Part 801 Subpart D) Subpart C)
(21 CFR Part 801
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k.092051
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