(26 days)
Not Found
No
The device description and intended use focus on a liquid control solution for verifying the performance of a lead analyzer. There is no mention of AI, ML, or any computational analysis of data beyond standard analytical performance testing.
No.
The device is a quality control material used to monitor and evaluate the analytical performance of a lead measurement analyzer, not to directly treat a patient's medical condition. It is for "In Vitro Diagnostic Use."
No
The device is a quality control material used to assess the performance of a lead measurement analyzer, not to diagnose a patient directly.
No
The device description clearly states the product is a liquid control solution packaged in glass vials, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states "For In Vitro Diagnostic Use".
- Purpose: The device is intended to "monitor and evaluate the analytical performance of the ESA Biosciences LeadCare II Analyzer for the measurement of lead in blood." This is a quality control material used in a laboratory setting to ensure the accuracy of a diagnostic test (measuring lead in blood).
- Context: The description places the device within the context of "good laboratory practice" and "quality control testing of the sensors, and verification of system performance" for a lead measurement system.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. In this case, the device is used to ensure the accuracy of a test that measures lead in blood, which is a specimen derived from the human body.
N/A
Intended Use / Indications for Use
LeadCare II Lead Controls are intended for use as a quality control to monitor the precision of measurement and verify the performance of the ESA Biosciences LeadCare II System at two distinct levels within the measurement range.
ESA Biosciences LeadCare II Control is intended to be used to monitor and evaluate the analytical performance of the ESA Biosciences LeadCare II Analyzer for the measurement of lead in blood. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of lead provided by the controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
The ESA LeadCare II Control is customized for use on the ESA Biosciences LeadCare II Lead Analyzer and are used to verify the performance of the LeadCare II analyzers and sensors for the measurement of lead. The control solution is an aqueous solution containing bovine albumin, lead, buffers, preservative and dye in concentrations determined optimal for the LeadCare II system. The product is provided in two distinct levels, in screw capped, glass vials, each containing 2 mL of solution. One set of controls will be packaged with each LeadCare II test kit for use in quality control testing of the sensors, and verification of system performance.
LeadCare II Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle.
LeadCare II Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted to verify specific performance requirements:
- a) Preservative Efficacy
- b) Closed bottle stability
- c) Stability after opening
- d) Comparison to predicate device
- e) Test precision and range
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
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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
Image /page/0/Picture/0 description: The image shows the number 1063398 at the top. Below that is the word BIONOSTICS in bold font. There is a crescent moon shape in the middle of the image. The words FERRARIS Quality Solutions are at the bottom right of the image.
510(k) Summary1
DEC - 5 2006
- (a) (1) Submitter's name, address Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Randy Byrd Chief Technical Officer (978) 772-7070 x 272
Date of preparation of this summary: 8 November 2006
- (2) Device trade or proprietary name: LeadCare II Lead Controls Device common or usual name or classification name:
Clinical Toxicology Control Material
| CLASSIFICATION | |||
|---|---|---|---|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| Clinical Toxicology Control Material | 862.3280 (D/F) | 1 | Toxicology |
I. Substantial Equivalence
ESA LeadCare II Lead Control is substantially equivalent in function, safety and efficacy to the Kaulson Laboratories Heavy Metal Control currently distributed with the LeadCare II test kits.
| Characteristic | New Device | Predicate Device |
|---|---|---|
| Name: | LeadCare II Lead Control | Kaulson Labs LeadCare Lead Control |
| 510(k): | -- | K830234 |
| Description: | Aqueous solution containing bovine albumin, | |
| lead salts, preservatives and dye. | Lyophilized whole bovine blood with pre- | |
| measured water for dilution | ||
| Intended Use: | LeadCare II Lead Controls are intended for | |
| use as a quality control to monitor the | ||
| precision of measurement and verify the | ||
| performance of the ESA Biosciences | ||
| LeadCare II System at two distinct levels | ||
| within the measurement range. | LeadCare Lead Controls are intended for | |
| use as a quality control to monitor the | ||
| precision of measurement and verify the | ||
| performance of the ESA Biosciences | ||
| LeadCare II System at two distinct levels | ||
| within the measurement range. | ||
| Levels: | 2 | 2 |
| Analytes: | Lead | Lead |
Comparison of Technological Characteristics with Predicate Device
l This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
II. Description of the new device
The ESA LeadCare II Control is customized for use on the ESA Biosciences LeadCare II Lead Analyzer and are used to verify the performance of the LeadCare II analyzers and sensors for the measurement of lead. The control solution is an aqueous solution containing bovine albumin, lead, buffers, preservative and dye in concentrations determined optimal for the LeadCare II system. The product is provided in two distinct levels, in screw capped, glass vials, each containing 2 mL of solution. One set of controls will be packaged with each LeadCare II test kit for use in quality control testing of the sensors, and verification of system performance.
LeadCare II Control provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a glass bottle.
LeadCare II Control is a non-hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
(5) Intended use of the device
LeadCare II Lead Controls are intended for use as a quality control to monitor the precision of measurement and verify the performance of the ESA Biosciences LeadCare II System at two distinct levels within the measurement range.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements:
- a) Preservative Efficacy
- b) Closed bottle stability
- c) Stability after opening
- d) Comparison to predicate device
- e) Test precision and range
- (b) (2) Summary of clinical tests submitted with the premarket notification for the device.
N/A
(b) (3) Conclusions drawn from the clinical and non-clinical trials. Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human figures in the negative space of the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Randy Byrd Chief Technical Officer Bionostics, Inc. 7 Jackson Road Devens, MA 01434
DEC - 5 2006
Re: K063398 Trade/Device Name: ESA Biosciences LeadCare II Lead Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology control material Regulatory Class: Class I, reserved Product Code: DIF Dated: November 8, 2006 Received: November 9, 2006
Dear Mr. Byrd:
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 Mav 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 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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K063398
Device Name: ESA Biosciences LeadCare II Control
Indications For Use:
ESA Biosciences LeadCare II Control is intended to be used to monitor and evaluate the analytical performance of the ESA Biosciences LeadCare II Analyzer for the measurement of lead in blood. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of lead provided by the controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
Prescription Use (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)
0
Carol Benam
sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
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