(224 days)
No
The document describes a quality control material for a clinical chemistry analyzer and does not mention any AI or ML components.
No.
This device is a quality control used to monitor the performance of an in-vitro diagnostic test, not to treat a condition.
No
The device is a quality control material used to monitor the performance of an immunoturbidimetry determination, not to diagnose a patient.
No
The device is a liquid quality control solution, which is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry." This clearly indicates it's used in vitro (outside the body) to assess the accuracy and reliability of a diagnostic test (Micro ALBUMIN CP determination).
- Device Description: The description details a "quality control consisting of liquid solutions prepared from human urine with added chemicals, constituents of human origin, stabilizers and preservatives." This is a typical description of a reagent or control used in laboratory testing.
- Monitoring Performance of a Diagnostic Test: The core function is to ensure the proper functioning of a diagnostic assay (ABX Pentra Micro ALBUMIN CP determination). This is a key characteristic of an IVD control.
- Predicate Device: The mention of a predicate device (K072835; Liquichek Microalbumin Control) which is also a quality control for microalbumin, further supports its classification as an IVD.
Therefore, the ABX Pentra Micro ALB Control L/H fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The ABX Pentra Micro ALB Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with added chemicals, constituents of human origin, stabilizers and preservatives. The assigned values and precise confidence interval are given in an enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the HORIBA clinical chemistry analyzer. Each control level is provided in one vial of 10 ml.
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)
Real time stability studies were conducted to establish the shelf life and open vial stability claims. Acceptance criteria were met to support the product claims as follows:
Shelf Life: 24 months at 2 to 8°C. Open vial stability: 90 days at 2 to 8℃.
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.
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
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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SECTION 006 : 510(k) Summary
ABX Pentra Micro ALB Control L/H 510(k) Number: K133676
510(k) Summary ABX Pentra Micro ALB Control L/H
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: K133676
1.0 Submitter
Horiba ABX SAS Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 18 43 Telephone: Fax: + (33) 4 67 14 15 17
Contact Persons
Caroline Ferrer, Regulatory Affairs Manager (caroline.ferrer@horiba.com) Christelle Calvo, Regulatory Affairs Support (christelle.calvo@horiba.com)
Date of Summary Preparation
July 08, 2014
2.0 Device Identification
The following control is for use in conjunction with the ABX PENTRA 400 instrument, cleared to market under K052007.
| Trade/Proprietary Name: | ABX Pentra Micro ALB Control L/H |
|---|---|
| Model Number: | A11A01967 |
| Common or Usual Name: | Micro ALB Control |
| Device Class | Class I |
| Classification Panel: | Clinical Chemistry |
| Regulation: | 21 CFR § 862.1660 Quality control material |
| (assayed and unassayed) | |
| Product Code: | JJY; Multi-Analyte Controls, All Kinds (Assayed) |
3.0 Device to Which Substantial Equivalence is Claimed
Liquichek Microalbumin Control Bio-Rad Laboratories Irvine, California 510 (k) Number: K072835
· HORIBA ABX SAS, FRANCE
Section 006-1
1
4.0 Description of Device
The control included in this submission is for use on the ABX PENTRA 400 (K052007) which is discrete photometric benchtop clinical chemistry analyzer. There is no any modifications to the cleared instrument for this particular assay.
The ABX Pentra Micro ALB Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with added chemicals, constituents of human origin, stabilizers and preservatives. The assigned values and precise confidence interval are given in an enclosed annex, ensuring control of the appropriate HORIBA ABX SAS methods on the HORIBA clinical chemistry analyzer. Each control level is provided in one vial of 10 ml.
5.0 Value Assignment
Assigned values were determined by calculating the mean value obtained from multiple determinations. The concentration of the constituent(s) is lot specific. Assigned values and the corresponding ±3SD confidence ranges are indicated in a specific annex. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.
6.0 Intended use
ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.
7.0 Comparison of the new device with the Predicate Device
The new ABX Pentra Micro ALB Control L/H claims substantial equivalence to the Liquichek Microalbumin Control currently in commercial distribution (K072835).
Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.
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| Predicate device (K072835): | New Device : | ||
|---|---|---|---|
| Device Name | Liquichek Microalbumin | ||
| Control | ABX Pentra Micro ALB Control L/H | ||
| Differences | |||
| Commercialized by | Bio-Rad Laboratories | HORIBA ABX SAS | |
| Indication for Use : | Liquichek Microalbumin Control | ||
| is intended for use as an assayed | |||
| quality control material to | |||
| monitor the precision of | |||
| laboratory testing procedures for | |||
| the analytes listed in the package | |||
| insert. | ABX Pentra Micro ALB Control L/H is a | ||
| quality control used to monitor the | |||
| performance of ABX Pentra Micro | |||
| ALBUMIN CP determination by | |||
| immunoturbidimetry. | |||
| Analytes | Microalbumin and creatinine | Microalbumin | |
| Similarities | |||
| Produced by | Bio-Rad Laboratories | Same | |
| Shelf Life | 2-8°C until expiration date | Same | |
| Open stability | 90 days at 2 to 8°C | Same | |
| Format / Packaging | In liquid form in 10mL vials for | ||
| both level 1 and level 2 | Same | ||
| Matrix | Human urine with added | ||
| constituents of human origin, | |||
| chemicals, preservatives and | |||
| stabilizers. | Same |
Table 1: Differencies and Similarities between predicate device and new device
8.0 Statement of Supporting Data
Real time stability studies were conducted to establish the shelf life and open vial stability claims. Acceptance criteria were met to support the product claims as follows:
Shelf Life: 24 months at 2 to 8°C. Open vial stability: 90 days at 2 to 8℃.
9.0 Conclusion
The performance testing data conclude that the safety and effectiveness of the devices are not compromised, and that they met all acceptance criteria, demonstrating that the device is substantially equivalent to its predicate device.
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
HORIBA ABX SAS C/O CAROLINE FERRER PARC EUROMEDECINE RUE DU CADUCEE MONTPELLIER 34184 FRANCE
Re: K133676
Trade/Device Name: ABX Pentra Micro ALB Control L/H Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: June 9, 2014 Received: June 13, 2014
Dear Ms. Caroline Ferrer:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Ms. Ferrer
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
hup://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133676
Device Name ABX Pentra Micro ALB Control L/I I
Indications for Use (Describe)
ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ruth A. Chesler -S
This section applies only to requirements of the Paperwork Reduction Act of 1995.
"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (1/14)