(188 days)
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No
The summary describes a standard in vitro diagnostic test system for measuring Urea/BUN levels using chemical reactions and a clinical chemistry instrument. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on method comparison and precision, which are standard evaluations for this type of device.
No
The device is an in vitro diagnostic (IVD) test system used to measure Urea/BUN concentration for diagnostic purposes, not for providing therapy or treatment.
Yes
The document explicitly states that the "Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma." and that "Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases."
No
The device description explicitly states it is a "test system" intended for "in vitro diagnostic measurement" using a "T60 instrument." It also describes calibrators and control serums, which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma." It also states "For in vitro diagnostic use on T60 instrument" for the test system, calibrator, and controls.
- Purpose: The purpose of the device is to measure a substance (Urea / BUN) in a sample taken from the human body (serum or plasma) to aid in the diagnosis and treatment of diseases. This is the core function of an in vitro diagnostic device.
- Components: The system includes a test system, calibrator (sCal), and control materials (Nortrol and Abtrol), which are typical components of an IVD system used for quantitative measurements.
- Regulatory Context: The mention of a predicate device (K991576) indicates that this device is being compared to a previously cleared IVD, further supporting its classification as an IVD.
Therefore, based on the provided information, this device clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
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.
Product codes (comma separated list FDA assigned to the subject device)
CDQ, JIX, JJY
Device Description
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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)
Comparison to Bayer ADVIA 2400
y = 0.94x + 0.25
R = 0.996
range from 4.3 to 117.3 mg/dL
N = 143
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Within run
Level 5.7 mg/dL
SD=0.2
CV(%)= 3.1
Level 14.7 mg/dL
SD=0.2
CV(%)= 1.4
Level 24.7 mg/dL
SD=0.4
CV(%)= 1.7
Level 44.8 mg/dL
SD=0.4
CV(%)= 0.8
Between run
Level 5.7 mg/dL
SD=0.4
CV(%)= 7.4
Level 14.7 mg/dL
SD=0.1
CV(%)= 1.0
Level 24.7 mg/dL
SD=0.4
CV(%)= 1.8
Level 44.8 mg/dL
SD=0.4
CV(%)= 1.0
Total
Level 5.7 mg/dL
SD=0.5
CV(%)= 8.1
Level 14.7 mg/dL
SD=0.4
CV(%)= 2.7
Level 24.7 mg/dL
SD=0.9
CV(%)= 3.6
Level 44.8 mg/dL
SD= 1.0
CV(%)= 2.2
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.
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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).
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§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in bold, and the word "SCIENTIFIC" is in a smaller font size below the first two words. The logo is in black and white.
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: K073295
Introduction: A.
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 Industrial Solutions and QRC | |||
| Date of Preparation: | November 19th, 2007 | ||
| C. | Device name | ||
| Proprietary name: | Urea / BUN, codes 981818 and 981820 | ||
| Common name: | Urea nitrogen | ||
| Classification: | Clinical Chemistry | ||
| Class: | II | ||
| Product Code: | CDQ | ||
| 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 |
Thermo Fisher Scientlfic Oy
Ratastie 2
P.O. Box 100 FIN-01621 Vantaa Finland
+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-lunnus 0921547-0
VAT No FI09215470 Domicile Helsinki
1
1
Urea / BUN
For in vitro diagnostic use in the quantitative determination of Urea / BUN (urea nitrogen) 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 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.
Ratastic 2 P.O. Box 100 FIN-01621 Vantas Finland
+358 (9) 329 100 tel +358 (9) 3291 0500 fax Y-tunnus 0921547-0 VAT No F109215470 Domicile Helsinki
2
E. Indications for use
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
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 Urea nitrogen (UN) assay.
G. Substantial equivalence -similarities
Urea / BUN is substantially equivalent to other devices legally marketed in United States. We claim equivalence to the Bayer ADVIA Urea Nitrogen (UN) assay (K991576).
Thermo Fisher Scientific Oy
Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland
+358 (9) 329 100 tel +358 (9) 3291 0500 fax
Y-tunnus 0921547-0 VAT No FI09215470 Domicile Helsinki
3
The following table compares the Urea / BUN with the predicate device Table 1 (Results as urea nitrogen mg/dL).
| Attribute | New device #1 | Predicate device #1 |
|---|---|---|
| Intended Use | For in vitro diagnostic use in the | |
| quantitative determination of Urea | ||
| / BUN (urea nitrogen) | ||
| concentration in human serum or | ||
| plasma on T60 instrument. | For in vitro diagnostic use in | |
| the quantitative determination | ||
| of urea nitrogen (an end | ||
| product of nitrogen | ||
| metabolism) in human serum, | ||
| plasma (lithium heparin), and | ||
| urine on the ADVIA | ||
| Chemistry systems. Such | ||
| measurements are used in the | ||
| diagnosis and | ||
| treatment of kidney disease, | ||
| urinary tract obstruction, and | ||
| acute or chronic renal | ||
| failure. | ||
| Indication for Use | The Urea / BUN test system is | |
| intended for quantitative in vitro | ||
| diagnostic measurement of urea / | ||
| BUN (urea nitrogen) | ||
| concentration in human serum or | ||
| plasma. Such measurements are | ||
| used in the diagnosis and | ||
| treatment of certain renal and | ||
| metabolic diseases. | See intended use. | |
| Assay Protocol | Urea is hydrolysed in the presence | |
| of water and urease to produce | ||
| ammonia and carbon dioxide. In | ||
| the presence of glutamate | ||
| dehydrogenase (GLDH) and | ||
| reduced nicotinamide adenine | ||
| dinucleotide (NADH), the | ||
| ammonia combines with a- | ||
| ketoglutarate ( $α$ -KG) to produce | ||
| L-glutamate. | ||
| The resulting decrease in | ||
| absorbance at 340 nm, as NADH | ||
| is converted to NAD, is | ||
| proportional to the level of urea in | ||
| the sample. | Urea is hydrolyzed in the | |
| presence of water and urease | ||
| to produce ammonia and | ||
| carbon dioxide. The ammonia | ||
| reacts with 2-oxoglutarate in | ||
| the presence of glutamate | ||
| dehydrogenase and NADH. | ||
| The oxidation of NADH to | ||
| NAD is measured as an | ||
| inverse rate reaction at | ||
| 340/410 nm. | ||
| Traceability/Standar | ||
| dization | The value of Urea / BUN has | |
| been assigned by using NIST | ||
| SRM 909b as a primary reference | The ADVIA UN method is | |
| traceable to the CDC | ||
| reference method, which uses | ||
| reference materials from the | ||
| National Institute of Standards | ||
| and Technology (NIST). via | ||
| patient sample correlation, | ||
| Attribute | New device #1 | Predicate device #1 |
| Sample Type | Serum, plasma (Li-heparin) | Serum, plasma (Li-heparin) and urine |
| Reagent Storage | Reagents in unopened vials are stable at 2...8 °C until the expiration date printed on the label. | For all systems, unopened reagents are stable until the expiration date printed on the product label when stored at 2°-8°C. Do not freeze reagents. |
| Expected Values | Serum, adult: | |
| Urea Nitrogen: 6 - 20 mg/dl | ||
| (2.2 - 7.2 mmol/l) |
Urea: 13 - 43 mg/dl
(2.2 - 7.2 mmol/l) | Serum: 9 - 23 mg/dL
(3.2 – 8.2 mmol/L)
Urine 12 – 20 g/day
(0.43 – 0.71 mol/day) |
| Instrument | T60 and DPC T60i, DPC T60i Kusti | ADVIA® 2400 Chemistry system. |
| Measuring Range | Serum:
Urea nitrogen:
4.2 - 56 mg/dl
(1.5 - 20.0 mmol/l)
Urea:
9 - 120 mg/dl
(1.5 - 20.0 mmol/l) | Serum:
5 - 150 mg/dL
(1.8 – 53.6 mmol/L)
Urine:
35 - 1000 mg/dL
(12.5 - 357 mmol/L) |
| Attribute | New device #1 | Predicate device #1 |
| Precision | Within run
Level 5.7 mg/dL
SD=0.2
CV(%)= 3.1
Level 14.7 mg/dL
SD=0.2
CV(%)= 1.4
Level 24.7 mg/dL
SD=0.4
CV(%)= 1.7
Level 44.8 mg/dL
SD=0.4
CV(%)= 0.8 | Serum:
Within run
Level 19 mg/dL
SD=0.3
CV(%)= 1.4
Level 67 mg/dL
SD=0.3
CV(%)= 0.5
Level 81 mg/dL
SD=0.5
CV(%)=0.7 |
| | Between run
Level 5.7 mg/dL
SD=0.4
CV(%)= 7.4
Level 14.7 mg/dL
SD=0.1
CV(%)= 1.0
Level 24.7 mg/dL
SD=0.4
CV(%)= 1.8
Level 44.8 mg/dL
SD=0.4
CV(%)= 1.0 | Total
Level 19 mg/dL
SD=0.4
CV(%)= 2.2
Level 67 mg/dL
SD= 1.0
CV(%)= 1.5
Level81 mg/dL
SD= 1.3
CV(%)= 1.6 |
| | Total
Level 5.7 mg/dL
SD=0.5
CV(%)= 8.1
Level 14.7 mg/dL
SD=0.4
CV(%)= 2.7
Level 24.7 mg/dL
SD=0.9
CV(%)= 3.6
Level 44.8 mg/dL
SD= 1.0
CV(%)= 2.2 | Urine:
Within run
Level 453 mg/dL
SD=10.1
CV(%)= 2.2
Level 712 mg/dL
SD=28.6
CV(%)= 4.0 |
| | | Total
Level 453 mg/dL
SD= 15.2
CV(%)= 3.4
Level 712 mg/dL
SD= 30.6
CV(%)= 4.3 |
| Attribute | New device #1 | Predicate device #1 |
| Method Comparison | Comparison to Bayer ADVIA
2400
$y = 0.94x + 0.25$
R = 0.996
range from 4.3 to 117.3 mg/dL
N = 143 | Serum:
ADVIA 1650
$y = 1.01x + 0.0$
r = 1.000
N = 229
Range 5.1 -146.8 mg/dL
Reference Method
$y = 1.04x - 0.1$
r = 0.997
N = 50
Range 5.5-136.2 mg/dL
Urine:
ADVIA 1650
$y = 0.95x + 2.3$
0.995
N = 51
Range 76.0 - 982.0 mg/dL |
| Limitations | Lipemia:
No interference found up to 1000
mg/dL (10 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 58
mg/dL (1000 µmol/l) of
conjugated bilirubin.
Bilirubin, unconjugated:
No interference found up to 58
mg/dL (1000 µmol/l) of
unconjugated bilirubin. | Lipemia (from Intralipid):
No significant interference
found up to 625 mg/dl of
Intralipid.
Hemolysate:
No significant interference
found up to 525 mg/dl of
hemoglobin.
Bilirubin:
No significant interference
found up to 30 mg/dl. |
4
ﺒﺤﺮ
Thermo Fisher Scientific Oy
:
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
:
:
5
.
Thermo Fisher Scientific Oy
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No FI09215470
Domicile Helsinki
6
:
Thermo Fisher Scientific Oy
Ratastie 2
P.O. Box 100
FIN-01621 Vantaa
Finland
+358 (9) 329 100 tel
+358 (9) 3291 0500 fax
Y-tunnus 0921547-0
VAT No Fl09215470
Domicile Helsinki
:
ww.thermo.com
7
Image /page/7/Picture/11 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure 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 logo is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Thermo Fisher Scientific Oy c/o Mr. Päivi Sormunen Vice President of Industrial Solutions and QRC Ratastie 2, P.O. Box 100 01621 Vantaa, Finland
Re: K073295 Trade Name: Urea/Bun, sCal, Nortrol, Abtrol Regulation Number: 21 CFR 862.1770 Regulation Name: Urea Nitrogen Test System Regulatory Class: Class II Product Codes: CDQ, JIX, JJY Dated: March 20, 2008 Received: March 28, 2008
Dear Mr. 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.
MAY 2 9 2008
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).
8
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.
Yean 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
9
Indication for Use
510(k) Number (if known):
Device Name:
Urea / BUN, sCal, Nortrol, Abtrol
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
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 (OVD)
Carol Benson
Division Sign Of Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073295