For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers.

Device Description

Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels.

AI/ML Overview

The provided text describes a 510(k) summary for a new medical device, Precinorm® Universal Plus and Precipath® Universal Plus Control Sera, which are quality control products for in vitro diagnostics. The summary focuses on establishing substantial equivalence to a predicate device.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria. The 510(k) summary primarily compares the new device to a predicate device to demonstrate substantial equivalence, rather than detailing performance against acceptance criteria in a study.

Here's an analysis of why the requested information is absent from the provided text:

Acceptance Criteria and Reported Device Performance (Table 1): The document presents a comparison of characteristics between the modified device and the predicate device, including intended use, format, and levels, and stability. It does not define specific, quantitative analytical acceptance criteria (e.g., specific ranges for accuracy, precision, or recovery for each analyte) that the new device must meet, nor does it present "reported device performance" against such criteria. The "differences" section only lists additional analytes for which values are included in the new device, not performance benchmarks.
Sample Size and Data Provenance (Table 2): There is no mention of a test set, sample sizes used, or data provenance (country of origin, retrospective/prospective). The document focuses on the product characterization rather than a clinical or analytical study with a defined test set.
Number and Qualifications of Experts for Ground Truth (Table 3): Since no ground truth establishment for a test set is discussed, there is no information about experts or their qualifications.
Adjudication Method (Table 4): No adjudication method is mentioned as there's no data requiring adjudication.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study (Table 5): This type of study is relevant for imaging or diagnostic interpretation devices. The Precinorm® and Precipath® control sera are quality control products, not diagnostic interpretation algorithms. Therefore, an MRMC study is not applicable and not mentioned.
Standalone Performance (Table 6): Standalone performance, typically referring to algorithm-only performance, is not applicable to quality control sera. The document describes the characteristics of the control sera themselves, not an algorithm's performance.
Type of Ground Truth (Table 7): As there is no study evaluating diagnostic accuracy or similar, there is no mention of the type of ground truth used.
Sample Size for Training Set (Table 8): This device is a control serum, not an AI or machine learning algorithm that requires a training set. Hence, no training set sample size is provided.
How Ground Truth for Training Set was Established (Table 9): Not applicable for the same reason as above.

In summary, the provided 510(k) summary is for a quality control product and focuses on demonstrating substantial equivalence to a predicate device based on product characteristics and indications for use. It does not contain the detailed study information regarding acceptance criteria, test sets, ground truth establishment, or clinical performance studies that would be expected for a diagnostic device or AI algorithm.

Summary

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NOV 2 4 1999

K993360

510(k) Summary -- Precinorm® Universal Plus and Precipath® Universal Plus Control Sera

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 576 3723Contact person: Priscilla A. HamillDate prepared: October 4, 1999
Predicate device	Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera (K811832)
Device description	Roche Diagnostics Precinorm® Universal Plus and Precipath® Universal Plus Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels.

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510(k)*Summary – Precinorm® Universal and Precipath® Universal Plus Control Sera, continued

Intended use /Indication foruse	Roche Diagnostics Precinorm® Universal Plus and Precipath® UniversalPlus Control Sera is intended for quality control in the quantitativedetermination of substrates, electrolytes, lipids, enzymes, proteins, and drugs.The control is used for monitoring accuracy or precision for manualtechniques and assays from Roche on automated clinical chemistry analyzers.
Substantialequivalence	The most important modification of the device presented in this submission isthe inclusion of values for additional analytes. Similarities and differencesare presented in detail below.
Substantialequivalence -similarities	The following table compares Precinorm® Universal Plus and Precipath®Universal Plus Human Serum Controls, with the predicate device (currentlymarketed modified Precinorm® Universal and Precipath® Universal HumanSerum Controls.)

Characteristic	Precinorm® Universal Plusand Precipath® UniversalPlus Control Sera(Modified Device)	Precinorm® Universal andPrecipath® UniversalHuman Serum Controls(Predicate Device)
Intended Use	For quality control in thequantitative determination ofsubstrates, electrolytes, lipids,enzymes, proteins, and drugs.The control is used formonitoring accuracy orprecision for manualtechniques and assays fromRoche on automated clinicalchemistry analyzers.	For control of chemistryassays. This control materialis well suited for both manualand automated analyticalprocedures.
Format	Lyophilized pooled humansera with constituents addedas required to obtain desiredcomponent levels	Lyophilized pooled humanserum with constituents addedas required to obtain desiredcomponent levels
Levels	Two levels	Two levels

Comparison of Modified Device and Predicate Device

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510(k) Summary – Precinorm® Universal and Precipath® Universal Plus Control Sera, continued

Characteristic	Precinorm® UniversalPlus and Precipath®Universal Plus ControlSera(Modified Device)	Precinorm® Universaland Precipath® UniversalHuman Serum Controls(Predicate Device)
Stability	Stable at 2-8 °C until expiration date Reconstituted:✓ 2-8 °C - 5 days✓ 25° - 12 hrs✓ -20° - 1 month, withexceptions as noted in	Stable at 2-8 °C until expiration date Reconstituted:✓ 2-8 °C - 2 days✓ 10-24° - 8 hrs✓ -20° - 1 month, withexceptions as noted in

labeling

The new device includes values for additional analytes listed in the table below.

Additional analytes.
Albumin	Lithium
Bicarbonate	Magnesium
Gamma globulins	Salicylate
Copper	Total iron binding capacity
Digoxin	Thyroxine (T4)
GLDH	T-Uptake
Arylamidase	Unsaturated iron-binding capacity

Substantial equivalence -differences addition of constitutent analyte values

labeling

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human profiles or flowing lines. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nov 24 1999

Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

K993360 Re:

Trade Name: Precinorm® Universal Plus and Precipath® Universal Plus Control Sera Regulatory Class: I Product Code: JJY Dated: October 4, 1999 Received: October 6, 1999

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): NHA K 993360

Device Name: Precinorm® Universal Plus and Precipath® Universal Plus Control Sera

Indications For Use:

For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision both for manual techniques and assays from Roche on automated clinical chemistry analyzers.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)		OR		Over-The-Counter Use

2-96)

Rita E. Makin

(Division Sign-Off)
Division of Clinical Laboratory Devices

_ and_

Regulation Number and Section

§ 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.