TRACE REAGENT LINE FOR THE COBAS MIRA

K973869 · Trace America, Inc. · CKA · Jan 7, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973869
• Device Name: TRACE REAGENT LINE FOR THE COBAS MIRA
• Applicant: Trace America, Inc.
• Product Code: CKA · Clinical Chemistry
• Decision Date: Jan 7, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1030
• Device Class: Class 1

Intended Use

Intended for the the In Vitro, quantitative determination of ALT (L-Alanine;2-Oxoglutarate Aminotransferase EC2.6.1.2) in human serum on the Cobas MIRA® clinical chemistry system. This alanine aminotransferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine aminotransferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitus and cirrhosis) and heart diseases. CFR 862.1030

Device Story

TRACE Reagent Line consists of chemical reagents for use on the Cobas MIRA clinical chemistry system. Reagents are used by laboratory professionals in clinical settings to perform quantitative in vitro diagnostic assays on patient serum, plasma, or urine samples. The system automates the mixing of reagents with patient samples; chemical reactions produce measurable changes (e.g., colorimetric or enzymatic activity) detected by the analyzer. The analyzer provides quantitative results to the clinician, who uses these values to diagnose and monitor conditions such as liver disease, pancreatitis, diabetes, renal failure, and electrolyte imbalances. The device facilitates rapid, standardized diagnostic testing, aiding in clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagents for use on the Cobas MIRA clinical chemistry system. Sensing principle based on standard clinical chemistry enzymatic or colorimetric assays. System is a standalone automated analyzer component. No specific materials or software architecture details provided.

Indications for Use

Indicated for in vitro quantitative determination of various analytes (ALT, Amylase, AST, Direct/Total Bilirubin, Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Inorganic Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, UIBC, Uric Acid) in human serum, plasma, or urine for diagnosis and treatment of liver, heart, metabolic, renal, and pancreatic diseases.

Regulatory Classification

Identification

An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 7 199

David Johnston TAI Technical Director TRACE America, Inch 7260 Northwest 58th Street Miami, Florida 33166

Re : K973869 TRACE Reagent Line for the Cobas Mira Regulatory Class: II CKA, JFJ, CDQ, CEK, CGX, CHH, CIG, CIT, Product Code: JGY, JHB, JIY, JMO, KHS Dated: October 24, 1997 Received: October 28, 1997

Dear Mr. Johnston:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

Product Radiation Control provisions, or other Federal laws or requlations.

{1}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will*allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deboring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

se

Intended for the the In Vitro, quantitative determination of ALT (L-Alanine;2-Oxoglutarate Aminotransferase EC2.6.1.2) in human serum on the Cobas MIRA® clinical chemistry system.

This alanine aminotransferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine aminotransferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitus and cirrhosis) and heart diseases. CFR 862.1030

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AH On Awn

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

{3}------------------------------------------------

510(k) Number (if known): Device Name: _ TRACE REAGENT LINE FOR THE COBAS MIRA Indications for Use:

ﺔ

Intended for the the In Vitro, quantitative determination of KAMYLASE (1,4-%- D glucan glucanohydrolase EC3.2.1.1) in human serum and urine on the Cobas MIRA ® clinical chemistry system.

This Amylase test system is a device intended to measure the activity of the enzyme Amylase in serum and urine . Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) CFR 862.1070

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

.

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number h973869

{4}------------------------------------------------

ા

Intended for the the In Vitro, quantitative determination of AST (Aspartate aminotransferase EC2.6.1.1) in human serum on the Cobas MIRA ® clinical chemistry system.

This "aspartate aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liverand heart disease." CFR 862.1100

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

Concurrence of CDRH, Office of Device Evaluation (ODE) -----------------

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

310(K) Number: 973869

{5}------------------------------------------------

510(k) Number (if known): K97 3869

Device Name: TRACE REAGENT LINE FOR THE COBAS MIRA Indications for Use:

ﻴﻒ

Intended for the the In Vitro, quantitative determination of Direct Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system.

This "Direct Bilirubin test system is a device intended to measure the levels of bilirubin (direct) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** √
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k973869

{6}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Total Bilirubin in human serum on the Cobas MIRA ® clinical chemistry system.

This "Total Bilirubin test system is a device intended to measure the levels of bilirubin (Total) in plasma or serum. Measurements of levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, if used in the diagnosis and treatment of the liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block." CFR 862.1110

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Division Sign-Off)
Division of Clinical Laboratory evices
510(k) Number K973869

{7}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Calcium in human serum or urine on the Cobas MIRA ® clinical chemistry system.

This "Calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms" CFR 862.1145

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Divi
510(k) Number: K973869

{8}------------------------------------------------

ﺑ

Intended for the the In Vitro, quantitative determination of Total CO2 in human serum on the Cobas MIRA ® clinical chemistry system.

This " bicarbonatel carbon dioxide test system is a device intended to measure the total bicarbonate/carbon dioxide plasma, serum and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid base balance. " CFR 862.1160

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Clinical Laboratory Devicer
510(k) Number 973869

{9}------------------------------------------------

u

Intended for the the In Vitro, quantitative determination of Chloride in human serum on the Cobas MIRA ® clinical chemistry system.

This " Chloride test system is a device intended to measure the Chloride in plasma, serum, sweat and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. " CFR 862.1170

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Divis
510(k) Number
K973869

{10}------------------------------------------------

510(k) Number (if known): __ K97 3869

Device Name: TRACE REAGENT LINE FOR THE COBAS MIRA Indications for Use:

Intended for the the In Vitro, quantitative determination of Cholesterol in human serum on the Cobas MIRA ® clinical chemistry system.

This " Cholesterol test system is a device intended to measure the Cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. " CFR 862.1175

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

Concurrence of CDRH, Office of Device Evaluation-(ODE) ------------------

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Sigf

(Optional Format 1-2-96)

vion of Clinical Laboratory Devices

510(k) Number. K973869

{11}------------------------------------------------

se

Intended for the In Vitro, quantitative determination of Creatinine in human serum and urine on the Cobas MIRA ® clinical chemistry system.

This " Creatinine test system is a device intended to measure the Creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases,in monitoring renal dialysis, and a calculation basis for measuring other urine analytes. " CFR 862.1225

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use__

(Optional Format 1-2-96)

973869

OF

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

{12}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Glucose in human serum and urine on the Cobas MIRA ® clinical chemistry system.

This " Glucose test system is a device intended to measure the Glucose levels in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus,neonatal hypoglycemia , idiopathic hypoglycemia and pancreatic islet cell carcinoma. " CFR 862.1360

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

Concurrence of CDRH, Office of Device Evaluation (ODE) -----------------------------------------------------------------------------------------------------------------------

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Division Sign-Circa ivision ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 510(k) Number

{13}------------------------------------------------

u

Intended for the the In Vitro, quantitative determination of Iron in human serum on the Cobas MIRA ® clinical chemistry system.

This " Iron (non-heme) test system is a device intended to measure Iron (non-heme)in serum and plasma. Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia , hemochromatosis ( a disease associated with widespread deposit in the tissues of two iron containing pigments, hemosiderin and hemofuscin, and characterized by pigmentation of the skin) and chronic renal disease. " CFR 862.1410

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

OR

| (Division Sign- | |
|-----------------|---------|
| Division of C. | |
| 510(k) Number | K923869 |

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |

{14}------------------------------------------------

u

Intended for the In Vitro, quantitative determination of Magnesium in human serum and urine on the Cobas MIRA ® clinical chemistry system.

This " Magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnasemia (abnormally high levels of magnesium). " CFR 862.1495

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Option

(Division
Division
510(k) Num... k973869

(Optional Format 1-2-96)

{15}------------------------------------------------

Page 1 of of _________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): __ K97 3869 Device Name: TRACE REAGENT LINE FOR THE COBAS MIRA Indications for Use:

Intended for the the In Vitro, quantitative determination of Inorganic Phosphorus in human serum or urine on the Cobas MIRA ® clinical chemistry system.

This " Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases , and vitamin D imbalance. " CFR 862.1580

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Image /page/15/Picture/10 description: The image shows a document with the text "Division Sign-Off", "Division of Clinical Laboratory Devices", and "510(k) Number". The number "K973864" is also visible on the document. The text is slightly blurred and appears to be handwritten or stamped onto the document.

{16}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Total Protein in human serum on the Cobas MIRA ® clinical chemistry system.

This " Total Protein test system is a device intended to measure Total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney or bone marrow as well as other metabolic or nutritional disorders " CFR 862. 1635

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _-(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

OR

{17}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Triglycerides in human serum on the Cobas MIRA ® clinical chemistry system.

This " Triglyceride test system is a device intended to measure Triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. " CFR 862.1705

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Clinical Laboratory Services
510(k) Number: 9723869

{18}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Urea Nitrogen in human serum or urine on the Cobas MIRA ® clinical chemistry system.

This " urea nitrogen test system is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in whole blood, serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. " CFR 862.1770

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Image /page/18/Picture/11 description: The image shows a document with the text "(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number." written on it. There is a signature over the text, and the number "42973869" is written below the text. The text and signature are slightly tilted.

{19}------------------------------------------------

Intended for the the In Vitro, quantitative determination of Unbound Iron-Binding Capacity (UIBC) in human serum on the Cobas MIRA ® clinical chemistry system.

This " Iron-binding capacity test system is a device intended to measure Iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia. " CFR 862.1415

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Image /page/19/Picture/10 description: The image shows a document with the text "(Division Sign-Off) Division of Clinical Labora 510(k) Number" followed by the number 2973869. The text is slightly slanted and partially obscured by a signature. The document appears to be a form or record related to clinical laboratory divisions.

{20}------------------------------------------------

510(k) Number (if known):

Device Name: TRACE REAGENT LINE FOR THE COBAS MIRA Indications for Use:

Intended for the the In Vitro, quantitative determination of Uric Acid in human serum or urine on the Cobas MIRA ® clinical chemistry system.

This " Uric Acid test system is a device intended to measure uric acid in serum, plasma or urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. " CFR 862.1775

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1-2-96)

Division of Clinical Laboratory Devices
510(k) Number
K973869