Dear Valued Customer,

Abbott is excited to announce the availability of four new ARCHITECT and ALINITY Clinical Chemistry assays. As part of
our commitment to excellence in Clinical Chemistry, we will be launching more than 20 next-generation assays over the
next two years. Abbott’s investment in new Clinical Chemistry assays and ConCC will optimize your laboratory’s
productivity and build sustained operational excellence by delivering:
• Minimized frequency of cartridge changes with greater onboard stability and optimized kit configurations
• Reduced calibration frequency with longer calibration stability
• Simplified workflows with a single-level calibrator

This letter outlines the group of four ARCHITECT and four ALINITY assays:

Assay List Number Kit Configuration

04T0320 4 x 150
Architect LDH2
04T0330 4 x 500
04T9920 4 x 150
Alinity LDH2
04T9930 4 x 500
04S8720 8 x 200
Architect Alkaline Phosphatase 2
04S8730 8 x 600
04T8320 10 x 200
Alinity Alkaline Phosphatase 2
04T8330 10 x 590
04T0220 4 x 125
Architect Iron 2
04T0230 4 x 310
Alinity Iron 2 04T9820 4 x 225

Abbott’s next-generation Clinical Chemistry assays are new formulations that will replace the current assays you are using
today. Current on-market assays will be phased out approximately six months after the new list numbers become
available in your country. To ensure a smooth transition within your laboratory, and to support conversion studies, Abbott
is providing Data Equivalency Sheets summarizing comparative results of current to new assay performance and
Instructions for Use for each assay.

Your Abbott team of resourceful advocates looks forward to supporting you through these upcoming assay conversions.

Kind regards,

Tong Wai Ping

Senior Customer Experience Manager
Contact: waiping.tong@abbott.com
Appendix: Additional Assay Comparison Information

New Product Current Product

Assay List Number Kit Configuration Assay List Number Kit Configuration
04T0320 4 x 150
Architect LDH2 Architect LDH 02P5622 10 x 130
04T0330 4 x 500
04T9920 4 x 150
Alinity LDH2 Alinity C LDH 07P7420 4 x 300
04T9930 4 x 500

Architect Alkaline 04S8720 8 x 200 Architect Alkaline 07D5522 5 x 300

Phosphatase 2 04S8730 8 x 600 Phosphatase 07D5532 10 x 1136

Alinity Alkaline 04T8320 10 x 200 Alinity Alkaline

08P2020 10 x 400
Phosphatase 2 04T8330 10 x 590 Phosphatase

04T0220 4 x 125
Architect Iron 2 Architect Iron 06K9530 3 x 306
04T0230 4 x 310
Alinity Iron 2 04T9820 4 x 225 Alinity Iron 8P3920 10 x 230

MDA Registration Approval number

Assay List Number Registration no

Architect LDH2 04T0320 IVDB3326822-101995
 04T0330 IVDB3326822-101995
04T9920 IVDB3881722-101995
Alinity LDH2
04T9930 IVDB3881722-101995
04S8720 IVDB9544723-119166
Architect Alkaline Phosphatase 2
04S8730 IVDB9544723-119166
04T8320 IVDB7821423-119164
Alinity Alkaline Phosphatase 2
04T8330 IVDB7821423-119164
04T0220 IVDB4655522-107065
Architect Iron 2
04T0230 IVDB4655522-107065
Alinity Iron 2 04T9820 IVDB4149922-100429
04T0920 IVDB4238123-116220
Architect Total Bilirubin 2
04T0930 IVDB4238123-116220
Alinity Total Bilirubin 2 04U0520 IVDB4869223-119166

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