K Number
K073612
Device Name
URIC ACID (AOX), SCAL, NORTROL, ABTROL
Date Cleared
2008-05-23

(154 days)

Product Code
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout. For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy. For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Device Description
Not Found
More Information

No
The summary describes a standard in vitro diagnostic test for uric acid and does not mention any AI or ML components.

No.
The device is an in vitro diagnostic (IVD) test system intended for quantitative measurement of uric acid concentration, which is used for diagnosis and treatment decisions, not for therapy itself.

Yes
The "Intended Use / Indications for Use" section explicitly states that the Uric Acid (AOX) test system is used "in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout," and that it is for "in vitro diagnostic measurement." The other listed items (sCal, Nortrol, Abtrol) are all support materials for this in vitro diagnostic measurement.

No

The device is described as an in vitro diagnostic test system for measuring uric acid in human serum or plasma, intended for use on a specific instrument (T60). This indicates it is a reagent or kit used with a hardware instrument, not a standalone software device.

Yes, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

  • "The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma."
  • "For in vitro diagnostic use on T60 instrument."
  • "For in vitro diagnostic use for quantitative testing on T60 instrument."

These statements clearly indicate that the device is intended for use outside of the body to diagnose or treat conditions, which is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Uric Acid (AOX)
For in vitro diagnostic use in the quantitative determination of uric acid concentration in human serum or plasma on T60 instrument.

sCal, code 981831
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Abtrol
For in vitro diagnostic use for quantitative testing on T6() instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.

For sCal Calibrator, Nortrol and Abtrol see intended use.

Product codes (comma separated list FDA assigned to the subject device)

KNK, JIX, JJY

Device Description

Uric Acid (AOX)
For in vitro diagnostic use in the quantitative determination of uric acid concentration in human serum or plasma on T60 instrument.

sCal, code 981831
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Abtrol
For in vitro diagnostic use for quantitative testing on T6() instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

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)

Method Comparison
Comparison to Bayer ADVIA 2400
y = 1.06x - 0.12
R = 0.999
range from 0.3 to 12.6 mg/dL
N = 105

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision
Within run
Level 1.2 mg/ dL
SD=0.009
CV(%)= 0.8
Level 2.3 mg/ dL
SD=0.017
CV(%)= 0.7
Level 4.4 mg/dL
SD=0.030
CV(%)= 0.7
Level 8.9 mg/ dL
SD=0.045
CV(%)= 0.5

Between run
Level 1.2 mg/ dL
SD=0.015
CV(%)= 1.3
Level 2.3 mg/ dL
SD= 0.020
CV(%)= 0.9
Level 4.4 mg/ dL
SD= 0.030
CV(%)= 0.7
Level 8.9 mg/ dL
SD= 0.039
CV(%)= 0.4

Total
Level 1.2 mg/dL
SD= 0.026
CV(%)= 2.3
Level 2.3 mg/dL
SD= 0.038
CV(%)= 1.7
Level 4.4 mg/dL
SD= 0.123
CV(%)= 2.8
Level 8.9 mg/dL
SD= 0.094
CV(%)= 1.1

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.

K991576

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

§ 862.1150 Calibrator.

(a)
Identification. A 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. (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.

0

510(k) SUMMARY

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

The assigned 510(k) number is: K07 36 12.

A. Introduction:

According to the requirements of 21 CFR 807.92 the following information provides sufficent detail to understand the basis for a determination of substantial equivalence.

B.Submitter's information
Name:Thermo Fisher Scientific Oy
Address:Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland
Phone:+358 (9) 329 100 tel
Fax:+358 (9) 3291 0500 fax
Contact person:Päivi Sormunen, Vice President of QRC
Date of Preparation:December 10th, 2007
C.Device name
Proprietary name:Uric Acid (AOX), codes 981391 and 981788
Common name:Uric acid
Classification:Clinical Chemistry
Class:I
Product Code:KNK
Proprietary name:sCal, code 981831
Common Name:Calibrator, Multi-Analyte Mixture
Classification:Clinical Chemistry
Class:II
Product Code:JIX
Proprietary name:Nortrol, code 981043
Common Name:Multi-analyte Controls (Assayed and unassayed)
Classification:Clinical Chemistry
Class:I
Product Code:JJY
Proprietary name:Abtrol, code 981044
Common Name:Multi-analyte Controls (Assayed and unassayed)
Classification:Clinical Chemistry
Class:I
Product Code:JJY

1358 (9) 329 100 tel +358 (9) 3291 0500 fax

1

D. Intended Use

Uric Acid (AOX)

For in vitro diagnostic use in the quantitative determination of uric acid concentration in human serum or plasma on T60 instrument.

sCal, code 981831

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.

Nortrol

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Abtrol

For in vitro diagnostic use for quantitative testing on T6() instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Y-tunnus 0921 547-0 VAT No FI09215470 Domicile Helsmki

2

E. Indications for use

The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.

For sCal Calibrator, Nortrol and Abtrol see intended use.

F. Substantial Equivalence

Bayer Corporation, model Bayer ADVIA 2400 Chemistry System.

Bayer Corporation item: Bayer ADVIA Uric Acid (UA) assay.

G. Substantial equivalence -similarities

Uric Acid is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Uric Acid (UA) assay (K991576).

Y-tunnus 0921 547-0 VAT No F109215470 Domicile Helsinki

www.thermo.com

3

The following table compares the Uric Acid with the predicate device

AttributeNew device #1Predicate device #1
Intended UseFor in vitro diagnostic use in the
quantitative determination of uric
acid concentration in human
serum or plasma on T60
instrument.For in vitro diagnostic use in
the quantitative determination
of uric acid in human serum,
plasma and urine on the
ADVIA® 1650 Chemistry
system. Such measurements
are used in the diagnosis and
treatment of renal failure, gout
and eclampsia
Indication for UseThe Uric Acid test system is
intended for quantitative in vitro
diagnostic measurement of uric
acid concentration in human
serum or plasma. Such
measurements are used in the
diagnosis and treatment of
numerous renal and metabolic
disorders, including renal failure
and gout.See intended use.
Assay ProtocolUric acid is oxidized to allantoin
by uricase. The generated
hydrogen peroxide reacts with 4-
aminoantipyrine (4-AAP) and N-
ethyl-N-(hydroxy-3-sulfopropyl)-
m-toluidin (TOOS) to a blue
violet dye. The absorbance of the
formed colour is measured at 540
nm.The uric acid is converted by
uricase to allantoin and
hydrogen peroxide. A colored
complex is formed from
hydrogen peroxide, 4-
aminophenazone and TOOS
[N-ethyl-N-(2-hydroxy-
sulfopropyl)-3-methylaniline]
under the catalytic influence
of peroxide. The absorbance
of the complex is measured as
an endpoint reaction at 545
nm.
Traceability/Standar
dizationThe value of Uric Acid has been
assigned by using NIST SRM
909b as a primary reference.The ADVIA 1650 Uric Acid
method is traceable to the
CDC candidate reference
method, which uses
reference materials from the
National Institute of Standards
and Technology (NIST) via
patient sample correlation.
Sample TypeSerum, plasma (Li-heparin)Serum, plasma (Li-heparin)
and urine
Reagent StorageReagents in unopened vials are
stable at 2... 8 °C until the
expiration date printed on the
label, when protected from light.Store at 2°-8°C. Unopened
reagents are stable until the
expiration date printed on the
product label.
Expected ValuesSerum:
Serum, adult:
Male: 3.5 - 7.2 mg/dl
(210 - 420 µmol/l)
Female: 2.6 - 6.0 mg/dl
(150 - 350 µmol/l)Male: 3.5 - 7.2 mg/dL
(208 – 428 µmol/L)
Female: 2.6 - 6.0 mg/dL
(155 - 357 µmol/L)
Urine 250 - 750 mg/day
(1.48 – 4.43 mmol/day)
InstrumentT60 and DPC T60i, DPC T60i
KustiADVIA® 2400 Chemistry
system.
Measuring RangeSerum:
0.2 - 20.0 mg/dl
(10 - 1200 µmol/l)Serum:
0 - 20 mg/dL

Urine:
0 - 180 mg/dL |
| Precision | Within run
Level 1.2 mg/ dL
SD=0.009
CV(%)= 0.8
Level 2.3 mg/ dL
SD=0.017
CV(%)= 0.7
Level 4.4 mg/dL
SD=0.030
CV(%)= 0.7
Level 8.9 mg/ dL
SD=0.045
CV(%)= 0.5

Between run
Level 1.2 mg/ dL
SD=0.015
CV(%)= 1.3
Level 2.3 mg/ dL
SD= 0.020
CV(%)= 0.9
Level 4.4 mg/ dL
SD= 0.030
CV(%)= 0.7
Level 8.9 mg/ dL
SD= 0.039
CV(%)= 0.4 | Serum:
Within run
Level 3.9 mg/dL
SD=0.04
CV(%)= 1.1
Level 8.6 mg/dL
SD=0.10
CV(%)= 1.1
Level 10.0 mg/dL
SD=0.06
CV(%)=0.6

Total
Level 3.9 mg/dL
SD=0.07
CV(%)= 1.9
Level 8.6 mg/dL
SD=0.14
CV(%)= 1.6
Level 10.0 mg/dL
SD=0.23
CV(%)= 2.3

Urine:
Within run
Level 12.4 mg/dL
SD=0.14
CV(%)= 1.1
Level 23.9 mg/dL
SD=0.16
CV(%)= 0.7 |
| | Total | Total |
| | Level 1.2 mg/dL
SD= 0.026
CV(%)= 2.3
Level 2.3 mg/dL
SD= 0.038
CV(%)= 1.7
Level 4.4 mg/dL
SD= 0.123
CV(%)= 2.8
Level 8.9 mg/dL
SD= 0.094
CV(%)= 1.1 | Level 12.4 mg/dL
SD= 0.14
CV(%)=1.1
Level 23.9 mg/dL
SD= 1.24
CV(%)= 5.2 |
| Method Comparison | Comparison to Bayer ADVIA 2400
$y = 1.06x - 0.12$
R = 0.999
range from 0.3 to 12.6 mg/dL
N = 105 | Serum:
Technicon DAX
$y = 1.51x + 0.48$
r = 0.994
N = 154
Range 0.2 - 18.0 mg/dL

Reference Method
$y = 1.01x - 0.05$
r = 0.999
N = 49
Range 1.7-19.5 mg/dL

Urine:
Beckman CX7
$y = 1.03x - 0.5$
r = 0.989
N = 30
Range 8 - 91 mg/dL |
| Limitations | Lipemia:
No interference found up to 900 mg/dl (9 g/l) of Intralipid.

Hemolysate:
No interference found up to 1000 mg/dl (10 g/l) of hemoglobin

Bilirubin conjugated:
No interference found up to 11 mg/dl (200 µmol/l) of conjugated bilirubin

Bilirubin total:
No interference found up to 14 mg/dl (250 µmol/l) of unconjugated bilirubin. | Hemolysate:
No significant interference found up to 525 mg/dl of hemoglobin.

Bilirubin:
No significant interference found up to 30 mg/dl.

Triglycerides:
The effect of triglycerides has been measured at analyte concentrations 3.4 mg/dL and 8.9 mg/dL. The observed interference is expressed as an interference index. Please refer to ADVIA 1650 Uric Acid (UA) package insert. |

Ratastie 2
P.O. Box 100
FIN-01621 Vantaa

+358 (9) 329100 tel
+358 (9) 3291 0500 fax

Y-tunnus 0921 547-0
VAT No FI0921 5470
Domicile IIelsinki

www.thermo.com

4

I hermorisher S C I E N T I F I C

Thermo Fisher Scientific Oy

Ratastie 2
P.O. Box 100
FIN-01621 Vantaa

: 358 (9) 329 | 00 tel
+358 (9) 3291 0500 fax

Y-tunnus 0921 S47-0
VAT No FI09215470
Domicile Helsinki

5

·

+358 (9) 329 100 tel
+358 (9) 3291 0500 fax

6

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES / USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 3 2008

Thermo Fisher Scientific Oy c/o Ms. Päivi Sormunen, Vice President of Industrial Solutions & QRC Ratastie 2, P.O. Box 100 Fin-01621 Vantaa Finland

K073612 Re: Trade Name: sCal, Nortrol, Abtrol, Uric Acid (AOX) Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX, JJY, KNK Dated: April 2, 2008 Received: April 4, 2008

Dear Ms. Sormunen:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

7

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M.

Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

8

Indication for Use

510(k) Number (if known): CO736 12

Device Name: Uric Acid (AOX), sCal, Nortrol, Abtrol

The Uric Acid test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.

For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy

For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(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)

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

510(k) K073412