(25 days)
Not Found
No
The summary describes a calibration product for an in vitro diagnostic test and does not mention any AI or ML components or functionalities.
No.
The "Intended Use / Indications for Use" section clearly states this device is an "in vitro diagnostic product for the calibration" of a method, not for treating any condition.
No
The device, LOCI NTP CAL, is described as an "in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method." It is a calibrator, meaning it's used to set or adjust the accuracy of a diagnostic method or system, not to perform a diagnosis itself.
No
The device description clearly states it is a "frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative" and comes in vials, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the LOCI NTP CAL is an "in vitro diagnostic product".
- Function: The device is used for the calibration of a method (N-terminal pro-brain natriuretic peptide) on a chemistry system. Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests.
- Nature of the Product: The "Device Description" describes the product as a frozen liquid containing synthetic human N-terminal pro-brain natriuretic peptide in a matrix, which is consistent with the composition of a calibrator used in laboratory testing.
Therefore, based on the provided information, the LOCI NTP CAL is clearly an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXL™ integrated chemistry system with LOCl® Module.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The LOCI NTP CAL is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
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)
Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
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
§ 862.1150 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
OCT 1 0 2008
510(k) Summary of Safety and Effectiveness for the Dimension® EXL™ LOCI® NTP Calibrator (RC623)
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.
Ko82680
B. Date of Preparation: August 26, 2008
C. Proprietary and Established Names:
Dimension® EXL™ LOCI N-terminal Pro-Brain Natriuretic Peptide Calibrator (LOCI NTP Calibrator - RC623)
D. Applicant:
A. 510(k) Number: _
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: (302) 631-0376 Fax: (302) 631-6299
E. Regulatory Information:
-
- Regulation section: 21 CFR § 862.1150 Calibrator, Secondary
-
- Classification: Class II
-
- Product Code: JIT, Calibrator, Secondary
-
- Panel: Clinical Chemistry
F. Predicate Device:
The LOCI NTP Calibrator (RC623) is substantially equivalent to the Dimension Vista® PBNP Calibrator (KC676A) cleared under K080578.
G. Device Description:
The LOCI NTP CAL is a frozen liquid product containing synthetic human N-terminal pro-brain natriuretic peptide in bovine albumin matrix with stabilizers and preservative. The kit consists of ten vials, two vials per level (A, B, C, D, and E), 1.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
H. Intended Use:
The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXL ™ integrated chemistry system with LOCl® Module.
I. Substantial Equivalence Information:
The LOCI NTP Calibrator (RC623) and the predicate Dimension Vista® PBNP Calibrator (KC676A) were compared. A comparison of the important similarities and differences between the devices and the predicates is provided in the following table:
1
| Feature | LOCI NTP CAL | Dimension Vista® PBNP Flex®
Calibrator (KC676A)
(K080578) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The LOCI NTP CAL is an in vitro
diagnostic product for the calibration
of the N-terminal pro-brain natriuretic
peptide (NTP Cat. No. RF623)
methods on the Dimension® EXL™
integrated chemistry system with
LOCI® Module. | The PBNP CAL is an in vitro
diagnostic product for the calibration
of the N-Terminal Pro-Brain
Natriuretic Peptide (PBNP) method for
the Dimension Vista® System. |
| Analyte | Synthetic PBNP | Synthetic PBNP |
| Matrix | Bovine Albumin | Bovine Albumin |
| Form | Liquid, frozen | Liquid, frozen |
| Volume | Ten vials, two vials per level (A, B, C,
D, and E), 1.0 mL per vial. | Ten vials, two vials per level (A, B, C,
D, and E), 1.0 mL per vial. |
| Levels | Five Levels, (0, 250, 1500, 12,000,
36,750 pg/mL) | Five Levels, (0, 250, 1500, 12,000,
36,750 pg/mL) |
J. Conclusion:
The Dimension® EXL™ LOCI N-terminal Pro-Brain Natriuretic Peptide Calibrator (RC623) is substantially equivalent to the predicate Dimension Vista® PBNP Calibrator (KC676A) cleared under K0080578. Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines forming its body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", arranged in a circular fashion around the emblem.
Public Health Service
OCT 1 0 2008
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Mr. Victor Carrio Senior Manager of Regulatory Affairs P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101
Re: K082680
Trade Name: LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator (RC623) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIT Dated: September 12, 2008 Received: September 15, 2008
Dear Mr. Carrio:
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).
3
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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 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 not 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 tollit the (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
4
Indication for Use
K 7 8 2 6 8 3 510(k) Number (if known):
Device Name:
LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator (RC623)
Indication For Use:
The LOCI NTP CAL is an in vitro diagnostic product for the calibration of the Nterminal pro-brain natriuretic peptide (NTP Cat. No. RF623) method on the Dimension® EXL™ integrated chemistry system with LOCI® Module.
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)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082680
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