(12 days)
Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet. Precipath ® U Plus is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.
Precinorm ® U Plus/ Precipath ®U Plus is a quality control product consisting of lyophilized human sera with constituents added as required to obtain desired component levels. Concentrations of control components have been adjusted to represent normal and pathological ranges.
The provided text is a 510(k) summary for the Precinorm® Universal Plus and Precipath® Universal Plus Control Sera. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a predicate device already on the market. It describes the device, its intended use, and compares it to the predicate device.
However, the document DOES NOT contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document states that the new device is substantially equivalent to the currently marketed Roche Diagnostics Precinorm® U Plus/ Precipath® U Plus (K993360). The focus is on demonstrating that changes to certain characteristics (like stability and the origin of some biological additives) do not alter the substantial equivalence to the previously cleared predicate device.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study to prove they are met because the provided text does not contain this information. The document is a 510(k) summary focused on demonstrating substantial equivalence, not on presenting a study to meet specific performance acceptance criteria for a novel device.
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:
SEP 1 4 2004
510(k) Summary - Precinorm ® Universal Plus and Precipath ® Universal Plus Control Sera
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence |
|---|---|
| Device Name | Proprietary name: Roche Diagnostics Precinorm ® Universal Plus andPrecipath ® Universal Plus Control Sera (Precinorm® U Plus and Precipath® U Plus) |
| Common name : Control Sera | |
| Classification name: Multi-analyte controls, all kinds (assayed andunassayed) | |
| Device description | Precinorm ® U Plus/ Precipath ®U Plus is a quality control productconsisting of lyophilized human sera with constituents added as required toobtain desired component levels. Concentrations of control components havebeen adjusted to represent normal and pathological ranges. |
| Intended use | Precinorm ® U Plus/ Precipath ® U Plus are for use in quality control bymonitoring accuracy and precision for the quantitative methods as specified inthe enclosed value sheet |
| Continued on next page |
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510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued
| SubstantialEquivalence | Roche claims substantial equivalence to the currently marketed RocheDiagnostics Precinorm® U Plus/ Precipath ® U Plus (K993360). | ||
|---|---|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250(317) 521-3723 | ||
| Contact person: Theresa M. Ambrose | |||
| Date prepared: August 18, 2004 | |||
| SubstantialEquivalence –Devicecomparison | The table below compares Precinorm® U Plus/ Precipath ® U Plus with thepredicate device (currently marketed Precinorm® U Plus/ Precipath ® UPlus). |
| Characteristic | Precinorm® U Plus/ Precipath ®U Plus (Predicate device,K993360) | Precinorm® U Plus/ Precipath ® UPlus (Modified Device) |
|---|---|---|
| Intended Use | For use in the quality control ofRoche methods for the quantitativedetermination of substrates,electrolytes, lipids, enzymes,proteins, and selected drugs. Thecontrol is used for monitoringaccuracy or precision both formanual techniques and assays onautomated clinical chemistryanalyzers. | For use in quality control bymonitoring accuracy and precision forthe quantitative methods as specified inthe enclosed value sheet |
| Format | Lyophilized control serum based onhuman serum. Concentrations ofcontrol components have beenadjusted to represent normal andpathological ranges. | Same |
Continued on next page
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510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera ,Continued
| Substantial Equivalence - Device comparison (continued) | |||
|---|---|---|---|
| -- | --------------------------------------------------------- | -- | -- |
| Characteristic | Precinorm® U Plus/ Precipath ®U Plus (Predicate device,K993660) | Precinorm® U Plus/ Precipath ® UPlus (Modified Device) |
|---|---|---|
| Stability | UnopenedUntil expiration date at 2-8°C | UnopenedSame |
| Opened/reconstituted:12 hours at 25 °C5 days at 4°C1 month at -20°C when frozen once | Opened/reconstituted:12 hours at 15-25°C5 days at 2 to 8°C4 weeks at -15 to -25 °C when frozenonce | |
| Bicarbonate in reconstituted serum2 days in closed bottle1 hour in open bottleBilirubin in reconstituted serum(protected from light)2 hours at 25 °C1 day at 4°C2 weeks at -20°C when frozen once | Bicarbonate in reconstituted serumSameTotal bilirubin in reconstituted serum(protected from light)8 hours at 15-25°C24 hours at 2 to 8°C2 weeks at -15 to -25 °C when frozenonceDirect bilirubin in reconstituted serum | |
| Inorganic phosphorus inreconstituted serum (protected fromlight)5 hours at 25 °C1 day at 4°C1 month at -20°C when frozen once | (protected from light)4 hours at 15-25°C8 hours at 2 to 8°C2 weeks at -15 to -25 °C when frozenonce |
Continued on next page
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510(k) Summary - Precinorm ® Universal and Precipath ® Universal Control Sera, Continued
| Characteristic | Precinorm® U Plus/ Precipath ®U Plus (Predicate device,K993360) | Precinorm® U Plus/ Precipath ® UPlus (Modified Device) |
|---|---|---|
| ConstituentAnalytes frombiologicaladditives | • ALT (GPT)• AST (GOT)• Albumin• Aldolase• Alkaline Phosphatase• Amylase, total• Amylase, pancreatic• Cholesterol• Cholinesterase• Creatine kinase• γ-GT• GLDH• LD (LDH)• Lipase• Acid phosphatase• Total Protein | Same |
| Origin ofselectedbiologicaladditives | • Lipase from porcine pancreas• Albumin and total protein fromhuman serum | • Lipase from human pancreas(recombinant)• For Precinorm® U Plus: albuminand total protein from bovine serum• For Precipath ® U Plus: same |
Substantial Equivalence – Device comparison (continued)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or branches extending upwards. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the logo.
SEP 1 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, Ph.D. RAC Regulatory Affairs Principal Roche Diagnostics 9115 Hague Road PO Box 50457 Indianapolis, IN 46250-0457
K042389 Re:
K042367
Trade/Device Name: Precinorm® Universal Plus Precipath ® Universal Plus Control Sera Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 1, 2004 Received: September 2, 2004
Dear Dr. Ambrose:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Sector 710(x) premainted is substantially equivalent (for the indications referenced above and nave ucterinined the devices marketed in interstate for use stated in the enclosure) to regary manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edical Federal Food. Drug commerce prior to May 28, 1970, the chacmises with the provisions of the Federal Food, Drug, devices that have been recults in accordance while as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that ao not require approvate of the general controls provisions of the Act. The You may, therefore, market the device, subject to use gentration, listing of
general controls provisions of the Act include requirements for annual mistranding ond general controls provisions of the receiners required in the bronibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (sec above) into entrols. Existing major regulations affecting your device it may be subject to such additional confirent. Basing news 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In can be lound in Title 21, Code of Pederal regulation in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ issualles of a successful other requirements of the Act
that FDA has made a determination that your device complies with openaise - You must that FDA has made a delcrimiation that Jour averses by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21 comply with an the Act s requirements, moraling, and good manufacturing practice
CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), labeling (21 CFR Parts 60 Pailts (21 CFR Part 820).
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Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter while and you to begin mailing of substantial equivalence of your device to a legally premailed notification: "The Pice is 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, If you destions on the promotion and advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Pin o Diagiosao De Horanding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou thay ovant other general mormational 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, 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):
Device Name: Precinorm ® Universal Plus and Precipath ® Universal Plus Control Sera
Indications For Use:
Precinorm ® U Plus is for use in quality control by monitoring accuracy and precision for the Frechnorin ® O Fras is ropecified in the enclosed value sheet.
quantitative menods as specifical in the control by monitoring accuracy and precision for the Frecipatii & O Fras is specified in the enclosed value sheet.
X 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)
Albert Sontz
Division Sign-Of
Page 1 of 1 __
Office of In Vitro Diagnostia Device Evaluation and Safety
5100k K042387
24
§ 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.