(44 days)
Not Found
No
The document describes a quality control product for clinical chemistry, consisting of lyophilized human sera. There is no mention of any computational analysis, algorithms, or learning processes, which are characteristic of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a quality control product for monitoring the accuracy and precision of quantitative methods, not for diagnosing, treating, or preventing disease in humans.
No
The device is described as a quality control product used for monitoring the accuracy and precision of quantitative methods, not for diagnosing diseases or conditions in patients. It helps ensure the reliability of other diagnostic tests.
No
The device description clearly states it is a "quality control product consisting of lyophilized human sera," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets." This describes a product used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description states the product consists of "lyophilized human sera with constituents added as required to obtain desired component levels." This is a common format for IVD control materials.
- Predicate Device: The mention of predicate devices (K042389; Precinorm Universal Plus and Precipath Universal Plus) which are known IVD control materials further supports its classification as an IVD.
The purpose of this device is to ensure the reliability and accuracy of other diagnostic tests performed on patient samples, which is a core function of an IVD control.
N/A
Intended Use / Indications for Use
PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Product codes
JJY
Device Description
The PreciControl ClinChem Multi 1 and 2 are quality control products consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of the components in the controls have been adjusted to represent normal and pathological levels. The concentrations of the components in the controls are lot-specific and representative values are given in the enclosed value sheets.
PreciControl ClinChem Multi 1 and 2 are lyophilized controls based on human serum. The adjusted concentrations and activities of the control components are in the normal and pathological ranges.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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510(k) Summary – PreciControl ClinChem Multi 1 and 2
| Introduction | Roche Diagnostics Corporation hereby submits this 510(k) to provide notification of our intent to market new controls named PreciControl ClinChem Multi 1 and 2. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Rd. | |
| PO Box 50416 | |
| Indianapolis, IN 46250 | |
| Phone: (317) 521-3954 | |
| Fax: (317) 521-2324 | |
| Contact Person: Patrick Stimart | |
| Date prepared: July 16, 2010 | |
| Device Name(s) | Proprietary name(s): 1. PreciControl ClinChem Multi 1 and 2 |
| Common name(s): PCCC Multi 1 and 2 | |
| Classified under 21 CFR 862.1660 | |
| Classification name(s): Multi-analyte controls, all kinds (assayed and unassayed) | |
| Product Code: JJY | |
| Device Description | The PreciControl ClinChem Multi 1 and 2 are quality control products consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of the components in the controls have been adjusted to represent normal and pathological levels. The concentrations of the components in the controls are lot-specific and representative values are given in the enclosed value sheets. |
| Continued on next page |
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510(k) Summary – PreciControl ClinChem Multi 1 and 2, Continued .
PreciControl ClinChem Multi 1 and 2 are for use in quality control by Intended Use monitoring accuracy and precision for the quantitative methods as specified in the value sheets. and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi Roche claims substantial equivalence to the Roche Diagnostics Predicate Precinorm Universal Plus and Precipath Universal Plus (K042389). Device
Continued on next page
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510(k) Summary -- PreciControl ClinChem Multi 1 and 2, Continued
The following table compares the PreciControl ClinChem Multi 1 and Substantial equivalence -2 controls with the predicate device. similarities
| Characteristic | PreciControl ClinChem
Multi 1 and 2 controls | Precinorm U plus and Precipath
U plus controls (K042389) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl ClinChem Multi 1
and 2 are for use in quality
control by monitoring accuracy
and precision for the quantitative.
methods as specified in the value
sheets. | Precinorm U plus and Precipath U
plus are for use in quality control
by monitoring accuracy and
precision for the quantitative
methods as specified in the value
sheets. |
| Format | PreciControl ClinChem Multi 1
and 2 are lyophilized controls
based on human serum. The
adjusted concentrations and
activities of the control
components are in the normal and
pathological ranges. | Precinorm U plus and Precipath U
plus are lyophilized controls based
on human serum. The adjusted
concentrations and activities of the
control components are usually in
the normal and pathological ranges. |
| Stability | • Same
• Same | • Unopened: Stable at 2-8°C
until expiration date.
• Stability of components
after reconstitution*:
at 15-25 °C 12 hours
at 2-8 °C 5 days
at (-15)-(-25) °C 4 weeks
(when frozen once) |
| | *Exceptions stated for total
bilirubin, direct bilirubin, UIBC,
and ALT | *Exceptions stated for total
bilirubin, direct bilirubin and
Bicarbonate |
| Traceability | Same | Traceability of the target values is
given in the respective instructions
for use of the system reagents. |
| Value
Assignment | Same | Traceable through Master Lot to
standards or reference methods. |
| Constituent Analytes | | |
| PreciControl ClinChem
Multi 1 and 2 controls | Precinorm U plus and
Precipath U plus controls (K042389) | |
| Same | Alanine aminotransferase, Albumin,
Alkaline phosphatase, Amylase, Amylase
pancreatic, Aspartate aminotransferase,
Bilirubin direct, Bilirubin total, Calcium,
Chloride, Cholesterol, Cholinesterase,
Creatine kinase, Creatinine, Glucose,
gamma Glutamyltransferase, Iron,
Lactate, Lactate dehydrogenase, Lipase,
Lithium, Magnesium, Phosphate,
Potassium, Sodium, Total protein,
Triglycerides, Unsaturated iron -binding
capacity, Urea, Uric acid | |
| Not included | Acid phosphatase, Aldolase, Bicarbonate,
Copper, Digoxin, Glutamate
dehydrogenase, alpha Hydroxybutyrate
dehydrogenase, Leucine aminopeptidase,
Phospholipids, Thyroxine, T-uptake | |
| alpha 1 Acid glycoprotein, Antisteptolysin
O, alpha 1 Antitrypsin, Apolipoprotein A-
1, Apolipoprotein B, C Reactive protein,
Ceruloplasmin, Complement C3c,
Complement C4, Creatine kinase MB,
HDL-Cholesterol, Haptoglobin,
Immunoglobulin A, Immunoglobulin G,
Immunoglobulin M, LDL-Cholesterol,
Prealbumin, Transferrin, Ferritin | Not included | |
Continued on next page .
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510(k) Summary – PreciControl ClinChem Multi 1 and 2, Continued
The following table compares the PreciControl ClinChem Multi 1 and Substantial 2 controls with the predicate device. equivalence differences
4
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 consists of a stylized eagle head with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Roche Diagnostics Corp. c/o Mr. Patrick J. Stimart Regulatory Affairs Consultant 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0416
1 2010 SEP
K102016 Re:
Trade Name: Precicontrol Clinichem Multi 1 and 2 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: July 16, 2010 Received: July 19, 2010
Dear Mr. Stimart:
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, provisions facturing 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 (1 will), it thay be bacyce be found in Title 21, Code of Federal Regulations (CFR), Parts affecting your at 1100 on, 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 r lease be advised thas made a determination that your device complies with other not mount that I Driver any Federal statutes and regulations administered by other requirements of the Precess of the Act's requirements, including, but not I cocharagenetes: 1 od may sing (21 CFR Part 807); labeling (21 CFR Parts 801 and 11med to: registration and nisting (1 medical device-related adverse events) (21 807), incureal device reporting (reporting (requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Form
KID2016
510(k) Number (if known):
Device Name: PreciControl ClinChem Multi 1 and 2
Indications for Use:
PreciControl ClinChem Multi 1 and 2 are for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Prescription Use __ X ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature: Steve Dillon
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 14/02/16
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