The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

For in vitro diagnostic use.

Device Description

The Lp (a) Calibrators are a set of 5 levels required to establish the calibration curve of the Quantia Lipoprotein (a) reagents (K050487) for the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma using immunoturbidimetry technology on the ARCHITECT c Systems.

The Lp (a) Control are a set of 2 levels used to monitor the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma with the Quantia Lipoprotein (a) reagents (K050487) using immunoturbidimetry technology on the ARCHITECT c Systems.

Quantia Lp(a) Reagent included two equivalent reagents presentation that only differ on the geographic distribution zone:

Reference 7K00-40 Quantia Lp(a) Reagent (US) -
Reference 7K00-01 Quantia Lp(a) Reagent (EX-US)

Both Quantia Lp(a) Reagents reference will use the Lp(a) Calibrators and Lp(a) Control products.

The human serum used in the Lp(a) Calibrators and Lp(a) Control is nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV using FDA approved methods.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Lp(a) Calibrators and Lp(a) Control, based on the provided 510(k) summary:

Description of Device

The Lp(a) Calibrators and Lp(a) Control are for in vitro diagnostic use to assist in measuring Lipoprotein (a) concentration in human serum or plasma.

Device Components:

Lp(a) Calibrators: A set of 5 levels used to establish the calibration curve for the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.
Lp(a) Control: A set of 2 levels (Control I and Control II) used to monitor the quantitative measurement of Lipoprotein (a) concentration with the Quantia Lipoprotein (a) reagents on the ARCHITECT c Systems.

Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance
Stability (Unopened)	Calibrators and controls stable for 32 months when stored at 2 to 8°C.	Demonstrated stability for 32 months.
Recovery based on Assigned Values (Unopened Stability)	Recovery values within ±10% of assigned values for Calibrator levels 2 to 5. Recovery values within ±3 mg/dL of assigned value for Calibrator level 1. Recovery values within ±10% of assigned values for controls.	Met the specified recovery value criteria for all calibrator and control levels.
Stability (Reconstituted)	Calibrators and controls stable for 14 days when stored at 2 to 8°C.	Demonstrated stability for 14 days.
Recovery based on Established Mean (Reconstituted Stability)	Recovery values within ±10% of the established mean at Day 0.	Met the specified recovery value criteria.
Control I Target Value	10 to 30 mg/dL	Achieved target values within this range, as specified in the lot-specific value sheet.
Control I Acceptance Range	±25% of Control I target value	Achieved acceptance ranges within this percentage, as specified in the lot-specific value sheet.
Control II Target Value	30 to 70 mg/dL	Achieved target values within this range, as specified in the lot-specific value sheet.
Control II Acceptance Range	±20% of Control II target value	Achieved acceptance ranges within this percentage, as specified in the lot-specific value sheet.

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
  - Calibrator Value Assignment: 30 replicates for each level of the new manufactured calibrator lot, the Master lot, and the previously released calibrator lot.
  - Control Value Assignment: Data generated from multiple runs (specific number not provided) on the ARCHITECT c8000 System.
- Data Provenance: Not explicitly stated, but the applicant's address is in Llica d'Amunt, Barcelona, Spain, suggesting the studies were conducted there. The studies appear to be prospective for product development and validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is a clinical chemistry device, not an imaging device that relies on expert interpretation. The ground truth (assigned values for calibrators and controls) is established through analytical methods and comparisons to a Master lot, not by human experts in the traditional sense of image adjudication.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an imaging or diagnostic device that requires human adjudication of results. The "adjudication" is based on statistical analysis of quantitative measurements against established criteria and comparison to a Master lot.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a calibrator and control material for an automated clinical chemistry analyzer. It does not involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device (calibrators and controls) operates in conjunction with the Quantia Lp(a) reagents on the ARCHITECT c Systems. The performance described is essentially the "standalone" analytical performance of the calibrators and controls to provide accurate values. There's no human-in-the-loop component for the calibrators/controls themselves; they are reagents used by the automated system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the calibrators and controls is established via assigned values. These assigned values are determined:
  - For calibrators: By comparing to an "existing Master lot" of calibrators.
  - For controls: By repeated measurements on the ARCHITECT c8000 System using the Quantia Lp(a) Reagent, generating a mean value and acceptance ranges.
  - Traceability to a commercial EIA (Enzyme Immunoassay) method was used for in-house reference material establishment, as no international reference material exists for Lp(a) in mg/dL.
The sample size for the training set
- Not explicitly defined as a "training set" in the context of an AI/ML device. For value assignment and stability studies:
  - Value Assignment Test: 30 replicates were used for each calibrator level.
  - Stability Studies: Involved comparing results over time to assigned values. The number of samples for the initial assignment and subsequent stability checks is not specified in detail beyond the 30 replicates for value assignment.
How the ground truth for the training set was established
- As noted above, this device doesn't have a "training set" in the AI/ML sense. The "ground truth" (assigned values for calibrators and controls) was established through:
  - Comparison to a Master lot for calibrators.
  - Multiple runs on the ARCHITECT c8000 System for controls to calculate their mean values and acceptance ranges.
  - In-house reference materials were value-assigned using a commercial EIA method due to the lack of an international reference standard for Lp(a) in mg/dL.

Summary

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510(k) Summary

This summary of the 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: K132400

Preparation Date: December 17, 2013

Applicant Name:

Mr. Joan Guixer Director of Quality Assurance and Requlatory Affairs Biokit S.A. Telephone number: (+34) 93 860 90 00 Fax number: (+34) 93 860 90 29 Llica d'Amunt Barcelona, Spain 08186

Device Name:

Calibrator: Classification Name: Calibrator, Secondary Trade Name: Lp(a) Calibrators Common Name: Calibrator Governing Regulation: 21 CFR 862.1150 Device Classification: Class II Classification Panel: Clinical Chemistry Product Code: JIT

Device Name:

Control: Classification Name: Quality Control Material (assayed and unassayed) Trade Name: Lp(a) Control Common Name: Single analyte Controls Governing Regulation: 21 CFR 862.1660 Device Classification: Class I, reserved Classification Panel: Clinical Chemistry Product Code: JJX

Legally marketed device to which equivalency is claimed:

The Lp(a) Calibrators and Lp(a) Control is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalence to the currently marketed Quantia Lp(a) Standard and Quantia Lp(a) Control cleared under K050487.

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Intended Use of Device:

The Lp (a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

The Lo (a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

Description of Device:

Quantia Lp(a) Reagent included two equivalent reagents presentation that only differ on the geographic distribution zone:

Reference 7K00-40 Quantia Lp(a) Reagent (US) -
Reference 7K00-01 Quantia Lp(a) Reagent (EX-US)

Both Quantia Lp(a) Reagents reference will use the Lp(a) Calibrators and Lp(a) Control products.

The human serum used in the Lp(a) Calibrators and Lp(a) Control is nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV using FDA approved methods.

Stability

Unopened Lp(a) Calibrators and Lp(a) Control are stable for 32 months when stored at 2 to 8°C.

Real time shelf life is determined by comparing results of the calibrators and controls stored at 2 to 8°C with their assigned values. The Lp(a) Calibrators and Lp(a) Control were considered stable if the recovery values were within ±10% of the assigned values for controls and calibrators level 2 to 5 and ±3 mg/dL of assigned value for calibrator level 1.

Once reconstituted, the calibrators and controls are stable for 14 days when stored at 2 to 8°C.

The reconstituted Lp(a) Calibrators and Lp(a) Control were considered stable if the recovery values were within ±10% of the established mean at Day 0.

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Value assigment

The value assignment for a new lot of Lp(a) Calibrators involves calibrating the Quantia Lp(a) on the ARCHITECT c8000 Clinical Chemistry System with the existing Master lot and running as samples, each level of the new manufactured calibrator lot, the Master lot and the previously released calibrator lot alternating the measurements until there are a total of 30 replicates for each material at each level.

The Control I and Control II mean values on the Lp(a) Control Value Sheet were calculated by data generated from multiple runs on the ARCHITECT c8000 System using the Quantia Lp(a) Reagent. The Control I and Control II target values should be within 10 to 30 mg/dL and 30 to 70 mg/dL respectively. Acceptance ranges are defined as ± 25% and ± 20% of Control I and Control II target values. The Control I and Control II lot specific target values and acceptable ranges are indicated on the Lp(a) Control Value Sheet included in the kit. It is recommended that each laboratory should establish its own Target values and Acceptance Range (mean and standard deviation).

Traceability

No reference material exists for Lp(a) in terms of mg/dL. In-house reference material was value-assigned using a commercial EIA (Enzyme Immunoassay) method.

Comparison of Technological Characteristics:

The Lp (a) Calibrators and Lp (a) Control are prepared from human sera containing Lp(a) with Kanamycin Monosulfate and Gentamicin Sulfate as preservatives. Both materials are indicated to be used in combination with the QUANTIA Lp(a) (K050487).

The currently marketed Quantia Lp(a) Standard and Quantia Lp(a) Control are prepared from human sera containing Lp(a) with sodium azide as preservative. Both materials are indicated to be used in combination with the QUANTIA Lp(a) (K050487).

Conclusion

The Lp(a) Calibrators and Lp(a) Control are substantially equivalent to predicate device (K050487).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of an eagle with three legs.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2013

BIOKIT S.A. JOAN GUIXER DIRECTOR OF QUALITY AND REGULATORY AFFAIRS CAN MALE, S/N LLICA d'AMUNT, BARCELONA 08186 SPAIN

Re: K132400

Trade/Device Name: Lp(a) Calibrators and Lp(a) Controls Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, JJX Dated: November 15, 2013 Received: November 18, 2013

Dear Mr. Guixer:

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.

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Page 2-Mr. Guixer

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR Part 807.97). 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Carol C. Benson -S for

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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Indications for Use

510(k) Number (if known): K132400

Device Name: Lp(a) Calibrators and Lp(a) Controls

Indications for Use:

ייר ביינוני מועד

Lp (a) Calibrators

The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

Lp (a) Controls

For in vitro diagnostic use.

Prescription Use _ X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ruth A. Chesler -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K132400 510(k)

SIOK Indication for Use ARCHITECT Lp(a) Calibrators and Controls Page 1 of 1 December 2013

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.