(465 days)
Not Found
No
The summary describes a standard in vitro diagnostic test using a colorimetric principle, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic reagent system used for quantitative determination of lithium to aid in patient management, not for direct therapeutic intervention.
Yes
Explanation: The device is used for the quantitative determination of lithium to aid in the management of patients taking lithium for mental disturbances, which is a diagnostic purpose.
No
The device description explicitly states it is an "in vitro diagnostic reagent system" and a "cassette" containing reagents, which are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "In vitro test for the quantitative determination of lithium in human serum and plasma". This clearly indicates it's used to test samples taken from the body, but the testing is done outside the body (in vitro).
- Device Description: States "The cassette cobas c501 Lithium contains an in vitro diagnostic reagent system". This directly labels the system as an in vitro diagnostic.
- Test Principle: Mentions a "colorimetric" principle, which is a common method used in laboratory testing of biological samples.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).
Product codes
NDW, JIX
Device Description
The cassette cobas c501 Lithium contains an in vitro diagnostic reagent system intended for use on Roche/Hitachi cobas c systems for the quantitative determination of lithium in human serum and plasma. The test principle is colorimetric.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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)
The cobas c501 test system was evaluated for several performance characteristics.
Key results:
Method comparison: Passing Bablok: y = 1.037x + 0.004 $\tau$ = 0.940. Linear regression: y = 1.044x -0.000 r = 0.995.
Precision: Within run CV: 1.7% @ 0.77 mmol/L, 1.0% @ 2.38 mmol/L, 1.9% @ 0.46 mmol/L, 1.2% @ 1.40 mmol/L. Total: 2.2% @ 0.79 mmol/L, 1.3% @ 2.42 mmol/L, 2.3% @ 0.61 mmol/L, 1.6% @ 1.62 mmol/L.
Endogenous interferences: No significant interference up to: Hemolysis: H index of 1000. Icterus: I index of 37 for conjugated and 43 for unconjugated bilirubin. Lipemia: L index of 2000.
Exogenous Interferences: NH4Cl: 19.8 umol/L, NaCl : 140 mmol/L, KCl : 4 mmol/ L, CaCl2: 2.4 mmol/L, MgCl2: 0.9 mmol/L, FeCl3: 1.04 mg/L, Cu (NO3)2: 1.15 mmol/L, ZnCl2: 1.07 mmol (none of these are in the physiological key interference range). In very rare cases gammopathy.
Limit of Detection: 0.05 mmol/L.
Limit of Blank: 0.03 mmol/L.
Measuring range: 0.05-3.00 mmol/L. Extended measuring range: 0.05-6.00 mmol/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
COBAS INTEGRA ISE Direct cleared as K963627
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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§ 862.3560 Lithium test system.
(a)
Identification. A lithium test system is a device intended to measure lithium (from the drug lithium carbonate) in serum or plasma. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).(b)
Classification. Class II.
0
510(k) Summary – cobas c501 Lithium
MAR 2 1 2008
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|---|---|
| Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 (317) 521-3723 |
| Contact person: Theresa Ambrose Bush | |
| Date prepared: January 14, 2008 | |
| Device Name | Proprietary name: Lithium |
| Common name: LI | |
| Classification name: Lithium | |
| Device Description | The cassette cobas c501 Lithium contains an in vitro diagnostic reagent system intended for use on Roche/Hitachi cobas c systems for the quantitative determination of lithium in human serum and plasma. |
| The test principle is colorimetric. | |
| Intended use | In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. |
| Predicate Device | We claim substantial equivalence to the COBAS INTEGRA ISE Direct cleared as K963627 |
| Substantial equivalency - Similarities | The table below indicates the similarities between the modified Lithium test and its predicate device (COBAS INTEGRA ISE Direct, K963627). |
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| Feature | Predicate device: ISE Direct
(K963627) | Modified device: Lithium |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use/
Indications for
Use | The ISE module of the COBAS
INTEGRA systems is intended for
use for the quantitative
determination of sodium, potassium,
chloride and lithium concentrations
in undiluted serum and plasma using
ion-selective electrodes. | In vitro test for the quantitative
determination of lithium in human
serum and plasma on
Roche/Hitachi cobas c systems. |
| Specimen type | Serum and plasma | Same |
| Test principle | | |
| Reference
method | Ion-selective electrodes using
undiluted specimens (ISE Direct) | Colorimetric test |
| Reagent information | | |
| Stability - shelf
life and on-board | 1 day at 15 to 25° C
7 days at 4° C
stable at -20 ° C | 1 day at 15 to 25° C
7 days at 2-8° C
6 months at (-15) to (-25) ° C |
| Calibrator | ISE Solutions 1, 2 and 3
ISE Calibrator Direct
5 hrs (main calibration) | C.f.a.s.
After 24 hrs, reagent pack change,
reagent lot change |
| | Every sample (one-point calibration) | |
| Quality control | Precinorm U and Precipath U | Precinorm U and Precipath U
Precinorm U plus and Precipath U |
| Traceability | Gravimetrically traceable to high
purity inorganic reference material | Atomic Absorption Spectroscopy |
| Performance characteristics | | |
| Expected values
(literature
reference) | Therapeutic concentration: 0.6-1.2
mmol/L
Toxic concentration:>2.0 mmol/L | Same |
| Method comparison | | |
| Method
comparison | Passing Bablok: y = 1.037x + 0.004
$\tau$ = 0.940 | |
| | Linear regression: y = 1.044x -0.000
r = 0.995 | |
| Feature | Predicate device: ISE Direct
(K963627) | Modified device: Lithium |
| Test principle | | |
| Reference
method | Ion-selective electrodes using
undiluted specimens (ISE Direct) | Colorimetric test |
| Performance characteristics | | |
| Precision | Within run CV:
2.5% @ 4.4 mmol/L
0.81% @ 1.9 mmol/L
Total:
3.4% @ 0.443 mmol/L
2.5% @ 33.2 mmol/L | Within run CV:
1.7% @ 0.77 mmol/L
1.0% @ 2.38 mmol/L
1.9% @ 0.46 mmol/L
1.2% @ 1.40 mmol/L
Total:
2.2% @ 0.79 mmol/L
1.3% @ 2.42 mmol/L
2.3% @ 0.61 mmol/L
1.6% @ 1.62 mmol/L |
| Endogenous
interferences | Hemolysis: levels higher than 1 g/L
increase lithium concentrations
significantly | No significant interference up to:
Hemolysis: H index of 1000 |
| | Icterus no significant interferences | Icterus: I index of 37 for conjugated
and 43 for unconjugated bilirubin |
| | Lipemia: highly lipemic specimens
may interfere with ISE fluid
detection causing the flag NO
FLUID | Lipemia: L index of 2000 |
| Exogenous
Interferences | Phenylpropamine and
pseudoephedrine interfere with the
membrane of the lithium electrode. | NH4Cl: 19.8 umol/L
NaCl : 140 mmol/L
KCl : 4 mmol/ L
CaCl2: 2.4 mmol/L
MgCl2: 0.9 mmol/L
FeCl3: 1.04 mg/L
Cu (NO3)2: 1.15 mmol/L
ZnCl2: 1.07 mmol
(none of these are in the
physiological key interference
range)
In very rare cases gammopathy |
| Limit of
Detection (per
CLSI EP17) | Not stated | 0.05 mmol/L |
| Limit of Blank | Not stated | 0.03 mmol/L |
| Measuring range | 0.1-4 mmol/L | 0.05-3.00 mmol/L
Extended measuring range: 0.05-
6.00 mmol/L |
2
Substantial The table below indicates the differences between the modified Lithium test
and its predicate device (COBAS INTEGRA ISE Direct, K963627). equivalency – Differences
3
Performance evaluation
The cobas c501 test system was evaluated for several performance characteristics.
In addition, the traceability, value assignment process, and stability of the lithium analyte within the c.f.a.s. calibrator are described.
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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 & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Dr. Theresa Ambrose Bush Regulatory Affairs Principal 9115 Hague Road Indianapolis. IN 46250
MAR 2 1 2008
Re: K063684 Trade/Device Name: Lithium Test System Regulation Number: 21 CFR 862.3560 Regulation Name: Lithium test system Regulatory Class: Class II Product Code: NDW, JIX Dated: March 7, 2008 Received: March 14, 2008
Dear Dr. Bush:
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).
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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 vour 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.
Jéan 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
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Indications for Use
510(k) Number (if known):
Image /page/6/Picture/2 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The characters are 'K063684'. The handwriting is cursive and the characters are connected.
Device Name: Lithium test system
Indications For Use:
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
063684